Tag: Product recall

FDA: Ventilator death, injury reports lower than initially reported

Editor's Note:  Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…

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By: Matt Danford
July 18, 2024
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FDA announces Class 1 recalls of ventilator, eye injection kits

Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…

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By: Matt Danford
July 16, 2024
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FDA announces Class 1 recalls for ventilator software, electrode pads

Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…

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By: Matt Danford
July 12, 2024
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FDA announces Class 1 recalls for upper airway stimulation system, MRI components

Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…

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By: Matt Danford
July 10, 2024
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FDA announces Class 1 recalls for ventilators, LVAS monitors

Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…

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By: Matt Danford
July 1, 2024
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FDA issues Class 1 recalls for two ventilator models

Editor's Note Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…

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By: Matt Danford
June 28, 2024
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FDA designates Class I recall for neurosurgery software

Editor's Note The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death. The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during…

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By: Matt Danford
June 5, 2024
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Class 1 recall announced for ambulatory infusion pump

Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…

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By: Matt Danford
May 31, 2024
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FDA announces class 1 recall for radiographic breast tissue marker

Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Hologic Inc.’s BioZorb Marker a class 1, indicating a risk of serious injury or death. BioZorb is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Provided sterile…

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By: Matt Danford
May 23, 2024
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Heart pump recall, lack of donor organs create concern for heart failure patients

Editor's Note The lack of available hearts for transplantation combined with the recent recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) “makes the current therapy landscape for heart failure much more dire,” according to a May 20 report in Medical Device Network. The recall of the device, which…

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By: Matt Danford
May 20, 2024
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