Class I recalls
No Class I recalls were reported for December 2011.
Class II recalls
| Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
| Varian Medical Systems; Inc. Oncology Systems | Dec-02-2011 | TrueBeam and TrueBeam STx; – TrueBeam and TrueBeam STx; Model Number: H19; Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions; tumors; and conditions anywhere in the body where radiation treatment is indicated. | An anomaly has been identified with the TrueBeam and TrueBeam STx systems where; under certain tuning conditions; the electron beam emerging from the bend magnet may have an elongated spot shape. |
| Philips Medical Systems (Cleveland) Inc | Dec-02-2011 | Ingenuity CT X-Ray System – Ingenuity CT computed Tomography System; Model #728326; 510(k) #K 033326; Serial Numbers: 300010 and 300018.The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems. |
| Philips Medical Systems (Cleveland) Inc | Dec-02-2011 | Brilliance CT X-Ray System – Brilliance 64 Computed Tomography System; Model #728231; 510(k) #K 033326; Serial Numbers: 95504; 91003; 300030; 95130; and 95157.The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems. |
| Integra LifeSciences Corp. | Dec-02-2011 | Integra LifeSciences – Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXProduct Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure. | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Maquet Inc. | Dec-02-2011 | Servo-i ventilator system – Maquet Servo-i ventilator systemDevice Part number 64 87 800Intended for treatment of and monitoring of patients in range of neonates; infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. | Servo-I and Servo–S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24). |
| Maquet Inc. | Dec-02-2011 | Servo-S ventilator system – Maquet Servo-S ventilator systemDevice Part number 66 40 440Intended for treatment of and monitoring of patients in range of neonates; infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. | Servo-I and Servo–S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24). |
| Integra LifeSciences Corp. | Dec-02-2011 | Integra LifeSciences – Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Integra LifeSciences Corp. | Dec-02-2011 | Integra LifeSciences – Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAUProduct Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure. | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Maquet Inc. | Dec-02-2011 | PC Board PC1772 Spare PArt – Maquet PC Board PC1772 Spare PartDevice Part number 64 67 620Intended for treatment of and monitoring of patients in range of neonates; infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. | Servo-I and Servo–S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24). |
| Bard Peripheral Vascular Inc | Dec-02-2011 | The EnCor¿ biopsy probe – The EnCor¿ biopsy probe; designed for use with EnCor¿ and EnCor¿ Enspire Vacuum Assisted Biopsy (VAB) driver systems.The EnCor¿ Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use. | This recall was voluntarily initiated by the firm due to the product ‘s damaged packaging trays; cracked EnCor (Trademark) packaging trays; plastic PETG tray the probe is packaged in was cracked. |
| Encore Medical; Lp | Dec-02-2011 | Foundation Tibial Broach – Foundation Tibial Broach P/N 801-01-013Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial Baseplate stem. P/N 801-01-013 | The strike plate may dislodge from the broach stem handle during impaction of the device. |
| Synthes USA (HQ); Inc. | Dec-02-2011 | Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive – Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive.This surgical instrument motor and accessories are AC-powered; battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur; chisel (osteotome); dermabrasion brush; dermatome; drill bit; hammerhead; pin driver and saw blade. | The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece; there is a potential for injury to the patient and/or user. |
| SCC Soft Computer | Dec-02-2011 | SoftReports – SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable; trained; and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases. | On 10/25/2011 SCC Soft Computer; Clearwater; FL initiated a correction on the SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. When SoftReports Designer opened a layout; the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page. All affected clients were notified on the issue on |
| Nanotherapeutics; Inc | Dec-02-2011 | Origen DBM with Bioactive Glass – Product is labeled in part – Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics; Inc. 13859 Progress Blvd; Suite 300 Alachua; FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" Product is labeled in part – Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics; Inc. 13859 Progress Blvd. Suite 300 Alachua; FL 32615***Rx Only***ONE EACH***"NanoFUSE DBM Catalog #:NAN109-02 (2cc size) NAN109-05 (5cc size)NAN109-10(10cc size)"Bone void filler comprised of a gelatin carrier; bioactive glass (45s5); and human demineralized bone matrix (DBM) intended for transplantation."Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis). | On 03/10/2011 Nanotherapeutics Inc; Alachua; FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc); 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011 |
| Nanotherapeutics; Inc | Dec-02-2011 | Origen DBM with Bioactive Glass – Product is labeled in part – Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics; Inc. 13859 Progress Blvd; Suite 300 Alachua; FL 32615 (386) 462-9663***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part – Carton label: "***Origen DBM with Bioactive Glass***REF***ID***Expiration***Manufactured for Blackstone Medical; Inc by: Nanotherapeutics; Inc. 13859 Progress Blvd. suite 300 Alachua; FL 32615***Distributed By: Orthofix Inc 1720 Bray Central Drive McKinney; TX 75069***Rx Only***ONE EACH***"Origen DBM with Bioactive Glass Catalog #:22-2002 (2cc size) 22-2005 (5cc size)22-2010 (10cc size)"Bone void filler comprised of a gelatin carrier; bioactive glass (45s5); and human demineralized bone matrix (DBM) intended for transplantation."Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis). | On 03/10/2011 Nanotherapeutics Inc; Alachua; FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc); 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011 |
| SCC Soft Computer | Dec-02-2011 | SoftPath GUI – SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable; trained; and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical; gynecological; medical cytological; and autopsy case specimens within the Pathology labs; for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. | On 07/20/2011 SCC Soft Computer; Clearwater; FL; initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results were from the previous order on the patient and not the current order. All affected clients were notified about the issue on 07/20/2011. |
| SCC Soft Computer | Dec-02-2011 | SoftPath GUI Versions: 4.3.0.10; 4.3.0.11; and 4.3.0.12. – SoftPath GUI Versions: 4.3.0.10; 4.3.0.11; and 4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable; trained; and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical; gynecological; medical cytological; and autopsy case specimens within the Pathology labs; for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. | On 06/13/2011; SCC Soft Computer initiated a correction on the following SoftPath GUI Versions: 4.3.0.10; 4.3.0.11; and 4.3.0.12. A client reported when they verified the contents of the fax reports; they found one of the specimen diagnoses to be missing. Parts A through D were present as well as Part F; however; Part E diagnosis was missing for one of the patient reports. All affected clients wer |
| RAYSEARCH LABORATORIES AB | Dec-02-2011 | RayStation – RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25; SE-111 34 Stockholm Sweden. support@raysearchlabs.comRayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment; and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. | The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect; thus enabling the user to make measurements that are erroneous and possibly misalign the patient. |
| Boston Scientific CRM Corp | Dec-01-2011 | LATITUDE¿ Patient Management System – LATITUDE¿ Patient Management System; Models 6441*; 6442*; 6465*; 6488 (USA).There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS; TELIGEN; and PUNCTUA; ENERGEN; and INCEPTA. The PUNCTUA; ENERGEN; and INCEPTA are not currently approved in the USThe LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time; there is only one (1) released version for each model number. The current version is 7.1.Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements. | Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms; and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However; the mea |
| Philips Medical Systems (Cleveland) Inc | Dec-01-2011 | Brilliance CT X-Ray System – Brilliance 64 Computed Tomography X-Ray System; 510(k) #K033326; Model Number: 728231; Serial Numbers: 9745; 90169; and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software. | Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software. |
| Radiometer America Inc | Dec-01-2011 | transcutaneous pCO2 electrodes – TC pCO2 Electrodes; Model/Part #945-655-E5260; 510(k) #K043003. Product Usage: The device is intended for used with the firm’s TCM series monitor. The E260mpCO2 electrode is a non-invasive device; used with the TCM series monitor to measure transcutaneous pCO2 (through the skin). | Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm’s TCM series monitors. This causes the monitor to interpret the electrode wrongly; causing it to fail all calibrations and never get ready for use. |
| Philips Medical Systems (Cleveland) Inc | Dec-01-2011 | Brilliance Big Bore CT X-Ray System – Brilliance Big Bore Computed Tomography X-Ray System; 510(k) #K033357; Model Number: 728243; Serial Numbers: 7298; and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 software. The Brilliance Big Bore and Brilliance 64 are Computed Tomography X-Ray Systems intended thio product cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software. |
| Elekta; Inc. | Dec-01-2011 | Synergy XVI kV Generator – Elekta Synergy XVI X-ray Volume Imaging SystemTo be used as part of radiation therapy treatment process. | A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board. |
| Varian Medical Systems; Inc. Oncology Systems | Dec-01-2011 | Head Ring Posts; of the Optical Guidance Platform and Floorstand devices – Head Ring Posts with part number 970.280 – re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices.Varian Medical Systems; Palo Alto; CA 94304.The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions. | An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage. |
| Elekta; Inc. | Dec-01-2011 | XVI R4.5 X-ray Volume Imaging System – Elekta Synergy XVI R.4.5 and R4.6ProducT Usage: To be used as part of radiation therapy treatment process. | The software did not operate as expected. |
| Zimmer Inc. | Dec-01-2011 | ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis – ZMR Over the Junction Instruments for Revision; utilized for the following ZMR devices: Porous Stem;Nitrited Porous Revision; Slotted Porous Bowed Stems with and without Compression Nut; Splined Straight Stem; Taper Stem and Bodies; Calcar Bodies; and Spout Bodies.Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head; neck or portions of the proximal femur. | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. |
| Zimmer Inc. | Dec-01-2011 | ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis – ZMR Crossover Instrumentation; utilized for the following ZMR devices: Porous Stem;Nitrited Porous Revision; Slotted Porous Bowed Stems with and without Compression Nut; Splined Straight Stem; Taper Stem and Bodies; Calcar Bodies; and Spout Bodies.Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head; neck or portions of the proximal femur. | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. |
| Zimmer Inc. | Dec-01-2011 | ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis – ZMR Porous Revision Hip Prosthesis Surgical Technique; utilized for the following ZMR devices: Porous Stem;Nitrited Porous Revision; Slotted Porous Bowed Stems with and without Compression Nut; Splined Straight Stem; Taper Stem and Bodies; Calcar Bodies; and Spout Bodies.Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head; neck or portions of the proximal femur. | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. |
| Zimmer Inc. | Dec-01-2011 | ZMR Porous Revision Hip Prosthesis and ZMR Revision Taper Hip Prosthesis – Zimmer ZMR Hip System Instructions for Use; utilized for the following ZMR devices: Porous Stem;Nitrited Porous Revision; Slotted Porous Bowed Stems with and without Compression Nut; Splined Straight Stem; Taper Stem and Bodies; Calcar Bodies; and Spout Bodies.Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head; neck or portions of the proximal femur. | This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use. |
| Philips Medical Systems (Cleveland) Inc | Dec-01-2011 | GEMINI TF 64 Diagnostic X-ray/PET Imaging System – Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System; Catalog/Model #882471; 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6; and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; brain; heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode; dynamic; and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. | In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers; the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur; it could impact the performance of reliability of the these PET/CT system units. |
| Philips Medical Systems (Cleveland) Inc | Dec-01-2011 | GEMINI TF 16 PET/CT X-ray Diagnostic Imaging System – Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System; 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. The GEMINI TF I6; and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body; brain; heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode; dynamic; and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. | In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers; the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur; it could impact the performance of reliability of the these PET/CT system units. |
| Acute Innovations Llc | Dec-01-2011 | RibLoc System; Standard Screw – 10mm x 2.7mm RibLoc Screw; a component of the RibLoc Rib Fracture Plating System; Model RBP1202.The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road; Suite 700 Hillsboro; OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE"The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures; fusions; and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib. | RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly. |
| Varian Medical Systems; Inc. | Dec-01-2011 | Brachytherapy System; Remote Afterloader – VariSource iX; Software Version 1.1; Part Number AL20020000 VariSource iX Afterloader.The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes; for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by; a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment. | VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment. |
| PerMedics; Inc. | Dec-01-2011 | Odyssey – OdysseyA radiation treatment planning system | Anomaly 1 – Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion; DICOM Image and RTP Link export files:During PerMedics’ internal code reviews for lEC 61217 compliance verification; an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan; D1COM RT Image and RTP Link. In some cases; this issue can result in table and/or collimator angle values t |
| Varian Medical Systems; Inc. Oncology Systems | Dec-01-2011 | GammaMed 12i Accessory – Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters; 1.8mm diameter; GammaMed 12i; Ref: BT-00264; Model 2-H63; Product is distributed by Varian Medical Systems Inc.; Palo Alto; CA and Manufactured by Varian Medical Systems Haan GmbH;Bergische Strasse 16; D-42781 Haan; Germany.The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy; in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial; intracavitary; intraluminal; intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. | The Product Models 1 & 2 have a design flaw problem where the clamping adapter canobstruct movement of the source cable in the event the bronchial catheter is dislodgedfrom the connector. |
| Varian Medical Systems; Inc. Oncology Systems | Dec-01-2011 | GammaMed 12i Accessory – Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters; 1.8mm diameter; GammaMed 12i; Ref: BT-00264; Model 1-H63; Product is distributed by Varian Medical Systems Inc.; Palo Alto; CA and Manufactured by Varian Medical Systems Haan GmbH;Bergische Strasse 16; D-42781 Haan; Germany.The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy; in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial; intracavitary; intraluminal; intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. | The Product Models 1 & 2 have a design flaw problem where the clamping adapter canobstruct movement of the source cable in the event the bronchial catheter is dislodgedfrom the connector. |
| Atom Medical Corporation | Dec-01-2011 | Infa Warmer i – Infa Warmer i (Atom Infant Warmer Model 103)Atom Medical Corporation 3-18-15 Hongo; Bunkyo-Ku; Tokyo; Japan 113-0033Usage: A warmer for infants. | The caster with lock on the radiant-warming open type incubator may become loose or break. |
| Atom Medical Corporation | Dec-01-2011 | Rabee Incu i – Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo; Bunkyo-Ku; Tokyo; Japan 113-0033Usage: An incubator for infants. | The caster with lock on the incubator may become loose or break. |
| Varian Medical Systems; Inc. | Dec-01-2011 | GammaMed Plastic Needle with Mandrin – GammaMed Plastic Needle with Mandrin; 2.0 mm diameter; length 200 mm. Remote controlled radionuclide applicator system. Varian Medical Systems; Inc. Mfg by Varian Medical Systems Haan GmbH; Haan; Germany.The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck; gynecology; breast or prostate. In order to avoid bending and to facilitate the introduction of the needles; each needle is supplied with a mandrin. | Plastic needle tip could possibly crack or separate. |
| Atom Medical Corporation | Dec-01-2011 | Incu i – Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo; Bunkyo-Ku; Tokyo; Japan 113-0033Usage: An incubator for infants. | The caster with lock on the incubator may become loose or break. |
| Atom Medical Corporation | Dec-01-2011 | Dual Incu i – Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo; Bunkyo-Ku; Tokyo; Japan 113-0033Usage: A combination incubator and warmer for infants. | The caster with lock on the incubator or infant warmer may become loose or break. |
| Varian Medical Systems; Inc. | Dec-01-2011 | GammaMed Plastic Needle with Mandrin – GammaMed Plastic Needle with Mandrin; 2.0 mm diameter; length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems; Inc. Mfg by Varian Medical Systems Haan GmbH; Haan; Germany.The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck; gynecology; breast or prostate. In order to avoid bending and to facilitate the introduction of the needles; each needle is supplied with a mandrin. | Plastic needle tip could possibly crack or separate. |
| Toshiba American Medical Systems Inc | Dec-01-2011 | Model CAT-850B Catheterization Table – Model CAT-850B Catheterization Table; a component of the Toshiba INFX-8000 series X-Ray Interventional System.These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system; support arms (that contain the tube and solid state detector); x-ray generator and a patient table. This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels; cerebral blood vessels; abdominal blood vessels and lower extremities. | The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table; the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop. |
| Varian Medical Systems; Inc. | Dec-01-2011 | GammaMed Plastic Needle with Mandrin – GammaMed Plastic Needle with Mandrin; 2.0 mm diameter; length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems; Inc. Mfg by Varian Medical Systems Haan GmbH; Haan; Germany.The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck; gynecology; breast or prostate. In order to avoid bending and to facilitate the introduction of the needles; each needle is supplied with a mandrin. | Plastic needle tip could possibly crack or separate. |
