Royal Philips issues urgent safety alert for fluoroscopy system
Editor's Note Royal Philips has issued an urgent field safety notice for its CombiDiagnost R90 GCF fluoroscopy system, the January 10 MassDevice reports. When the tilting feature is used, the device could be locked in a “Table Up/Down” state, an issue that could result in the entry of contrast agent…
FDA: Class I recall of Medfusion 4000 Syringe Pumps
Editor's Note The Food & Drug Administration (FDA) on December 19, 2019, identified the recall by Smiths Medical ASD, Inc of its Medfusion 4000 Syringe Pumps as Class I, the most serious. The recall was initiated because of malfunctioning low-battery alarms, which may lead to an interruption of therapy. The…
FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator
Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…
FDA: Class I recall of Cook Medical’s CrossCath Support Catheters
Editor's Note The Food and Drug Administration (FDA) on December 17 identified the recall by Cook Medical of its CrossCath Support Catheters as Class I, the most serious. The recall was initiated because of a manufacturing error that may cause the radiopaque marker bands on the catheters to dislodge or…
FDA: Medtronic recalls SynchroMed II implantable drug infusion pump
Editor's Note The Food and Drug Administration (FDA) on December 16 announced that Medtronic has recalled its SynchroMed II implantable infusion pump. The pump is being recalled because of the potential presence of foreign particles inside the pump motor assembly that may lead to a pump motor stall. Medtronic has…
FDA: B. Braun recalls blood administration sets
Editor's Note The Food & Drug Administration (FDA) on November 26 announced a voluntary recall by B. Braun Medical (Bethlehem, Pennsylvania) of 22 lots of blood administration sets. The recall was initiated because of the potential for leakage at the joint between the blood filters and tubing. This could force…
FDA updates device failure linked to Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on November 19 updated the device failure associated with Getinge’s Maquet/Datascope Intra-aortic Balloon Pumps (IABPs) in a letter to health care providers. Since 2017, the FDA has received more than 75 reports of the IABPs shutting down while running on battery. Five…
FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System
Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…
FDA: Class I recall of Philips Medical System’s Forte Gamma Camera System
Editor's Note The Food & Drug Administration (FDA) on November 4 identified Philips Medical System’s (Cleveland) recall of its Forte Gamma Camera System as Class I, the most serious. The recall was initiated because of the potential for the detector, which weighs 660 pounds, to become detached from the device…
FDA: Class I recall of Abbott CentriMag Circulatory Support System
Editor's Note The Food and Drug Administration on November 4 identified the recall by Abbott of its CentriMag Circulatory Support System as Class I, the most serious. The recall was initiated because of a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop,…
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