The U.S. Cyber Security & Infrastructure Security Agency (CISA) today issued a notice regarding the e-Alert system from Royal Philips (NYSE:PHG). CISA called attention to the e-Alert MRI system monitoring platform (version 2.7 and prior) and a potential vulnerability related to “missing authentication for critical function.” According to the CISA notice, successful exploitation of the […]
Recalls
Philips warns on software defect in some Azurion systems
Royal Philips (NYSE:PHG) has issued an urgent field safety notice about a software defect in its Azurion system. The notice, issued last month in Europe, informed users of a problem that can occur when the user selects the “Add Study” function to add a new study to a patient when using the Azurion image-guided therapy […]
Merit Medical Systems recalls some Access hemostasis valves
Merit Medical (Nasdaq:MMSI) issued an urgent field safety notice in Europe to alert users to a recall of some of its hemostasis valves. South Jordan, Utah-based Merit initiated the voluntary recall of its Access-9 and AccessPLUS hemostasis valves as a result of a defect relating to a recent design change made to improve manufacturability, according […]
Boston Scientific warns on some SpaceOAR systems
Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems. Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers […]
FDA orders Philips Respironics to improve communications over ventilator recall
The FDA issued a notification order alerting Philips (NYSE:PHG) that its notification efforts on the recall of its ventilators have been inadequate to date. Philips Respironics last year recalled millions of specific ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. […]
Tandem Diabetes warns on some t:slim X2 insulin pumps
Tandem Diabetes Care (Nasdaq:TNDM) issued an urgent field safety notice in Europe for its t:slim X2 insulin pump with Basal-IQ technology. The notice, dated February 2022, alerts users of Tandem’s insulin pump with a software version of 6.3.0.1 that there may be a potential safety risk when using the pump within its normal specifications. Tandem’s t:slim […]
Fresenius Kabi recalls sodium acetate injection due to presence of particulate matter
Fresenius Kabi USA announced today that it initiated the voluntary recall of seven lots of its sodium acetate injection. Lake Zurich, Illinois-based Fresenius Kabi recalled the USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or […]
Analysis: FDA medical device recalls drop to lowest levels since 2013
FDA medical device product recalls dropped by double digits last year to the lowest number since 2013, according to a Medical Design & Outsourcing analysis of newly released recall data from the regulatory agency. Device products recalled in fiscal year 2021 (ended Sept. 30) totaled 2,607, a 14.3% drop from the 3,042 recalls reported in fiscal 2020. […]
Baxter warns of alarm malfunction on some infusion pumps
Baxter (NYSE:BAX) announced today that it has issued an urgent safety communication regarding upstream occlusion alarms for certain infusion pumps. Deerfield, Illinois–based Baxter warned that incorrect administration set setup and/or the incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication. The problem might occur without the users receiving alerts […]
ResMed’s revenue growth off Philips will peak in present fiscal year, analysts say
Analysts say ResMed (NYSE:RMD) could see its seizure of the market share in respiratory devices slow with Philips (NYSE:PHG) set to re-enter the market. Philips was knocked out of the respiratory sleep devices market last year when it announced a serious recall involving millions of bi-level positive airway pressure (BPAP), continuous positive airway pressure (CPAP) […]
Medtronic issues voluntary recall for TurboHawk 6Fr Plus directional atherectomy system
Medtronic (NYSE:MDT) today announced that it issued a voluntary recall for its TurboHawk 6 French (6Fr) Plus directional atherectomy system. The recall for the TurboHawk Plus system relates to the risk associated with tip damage caused by guidewire prolapse. A recall for the HawkOne directional atherectomy system — associated with a similar issue — was […]
