The FDA announced that it is working to assess quality issues surrounding Level 3 surgical gowns and the PreSource procedural packs that contain them, all produced by Cardinal Health (NYSE:CAH). Both Dublin, Ohio–based Cardinal Health and the FDA agree that customers should immediately discontinue the use of all affected gowns and the packs that include them […]
Getinge issues urgent field safety notice for 88-series
Getinge (STO:GETI-B) issued an urgent field safety notice in Europe to warn customers of a potential leakage issue with its 88-5 washer disinfector. According to the safety notice out of Germany, the leakage may occur from the device in ruptured spot welds in the chamber, in some instances due to a worn door seal. The […]
Medtronic issues urgent field safety notice for O-arm imaging system
Medtronic (NYSE:MDT) announced that it determined that a replacement of the internal gantry tractor motor drive will resolve an issue with the O-arm O2 imaging system that the company warned customers of last year. In November, Medtronic notified customers of the potential for navigational inaccuracy with the O-arm O2 system’s auto-registration feature when used in conjunction […]
Gore announces some Excluder problems in Europe
W.L. Gore & Associates issued an urgent field safety notice in Europe to warn on issues with its Excluder AAA Endoprosthesis and Excluder Iliac Branch. Both Excluder products may experience the separation of the leading end of catheter components, according to the safety notice out of Germany. From January 2013 to Aug. 5, 2019, Gore […]
Philips issues urgent field safety notice for CombiDiagnost R90
Updated with a clarification from Philips. Royal Philips (NYSE:PHG) issued an urgent field safety notice to warn users of an issue with its CombiDiagnost R90 GCF fluoroscopy system. The imaging device used in radiography has shown an error issue when the table-tilting features are used. When using the “Table Up/Down” button on the device, Error 80, […]
Mavidon recalls LemonPrep, PediaPrep, Wave Prep, Cardio Prep tubes
Mavidon announced that it is recalling its LemonPrep, Pedia Prep, Wave Prep and Cardio Prep due to potential contamination. The company is recalling all lots of the specified products manufactured at its Riviera Beach, Fla.–based facility due to potential contamination with Burkholderia cepacia, which is an aerobic gram-negative bacillus found in various aquatic environments and […]
JAMA editorial slams FDA over adverse-event reporting
This article has been updated with comments from the FDA. A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting. Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which […]
Certain Mazor X robots could unexpectedly detach from OR table, Medtronic warns
This article has been updated with comments from Medtronic. Medtronic (NYSE:MDT) said today that some of its Mazor X surgical robotic systems could detach and fall onto the OR table, potentially injuring a patient. The problem affects Mazor X systems with posititioner Type II, the company said in an urgent field safety notice issued in the […]
Stryker issues voluntary field action for Lifepak 15 monitors/defibrillators
Stryker is launching a voluntary field action on certain units of its Lifepak 15 monitor/defibrillators. The company is notifying customers of an issue that could cause the devices to fail to deliver a defibrillation shock after pressing the “shock” button on the keypad. The problem stems from oxidation that forms over time within the button. […]
Mölnlycke issues safety notice for procedure trays
Mölnlycke issued an urgent field safety notice to warn of a potential safety issue with its procedure tray containing latex material. During an inspection, the company observed an error on the procedure tray labels. Information on the label states that the tray does not contain “natural rubber latex.” However, some components within the trays do […]
Smiths Medical recalls Medfusion 4000 due to issue with software update
Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a […]
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