FDA announces Class 1 recalls for nerve monitoring system, ambulatory infusion pumps
Editor's Note The US Food and Drug Administration (FDA) designated recalls of Medtronic’s NIM Vital Nerve Monitoring System and Smith Medical’s CADD-Solis Ambulatory Infusion Pumps as Class 1, the most severe category indicating serious risk of injury or death. Reports of false negative responses prompted Medtronic to recall the nerve…
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…
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…
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…
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…
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…
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…
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…
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…
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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