Baxter Hillrom Recalls Incontinence Management System Due to RF Interferences
Baxter Hillrom is recalling its incontinence management system following reports that its radio frequency emissions interferes with devices.
Tag: class 1 recall
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Medtronic Recalls Ventricular Assist Device Batteries
Medtronic is recalling HeartWare Ventricular Assist Device System batteries due to their ability to experience electrical faults that cause them to unexpectedly fail.
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Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect
Medtronic recalled its HeartWare Ventricular Assist Device System, which is designed to help the heart pump blood to the rest of the body.
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Baxter Hillrom Recalls Incontinence Management System Due to RF Interferences
Baxter Hillrom is recalling its incontinence management system following reports that its radio frequency emissions interferes with devices.
Medtronic’s HawkOne Recall Labeled Class I, Adding to Medtech’s Product Safety Problems
Medtronic’s Atherectomy System received a Class I recall from the FDA, the most serious type of recall which may lead to serious injuries or death.
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Medtronic’s Covidien Recall of Some Puritan Bennett Ventilators Is Class I
The U.S. FDA has revealed that Medtronic’s recall of certain Puritan Bennett ventilators is Class 1—which means that using the devices could result in serious patient harm or even death.
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FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines
The U.S. FDA is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines.
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Zimmer Biomet Software Error Prompts Class I Recall of Rosa One Robotic Neurosurgery Platform
A software error has prompted a Class I recall of the Zimmer Biomet Rosa One Brain platform, a robotic system that helps neurosurgeons position tools and implants during brain surgery.
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St. Jude Agrees to Pay $27M for Allegedly Selling Defective Heart Devices
The government alleges that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its implantable defibrillators.
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Boston Scientific Recalls Over 30,000 Stent Systems Due to Migration Risk
FDA deemed Boston Scientific’s recall of the Vici SDS and RDS venous stent system a Class I recall, reports MDDI.
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FDA Announces Class 1 Recall of Alaris Infusion Pump Module 8100 Bezel
Pacific Medical Group is recalling the Alaris Infusion Pump Module Model 8100 because the front bezel components may crack or separate.