FDA: Class I recall of specific Abiomed Impella 5.5 with SmartAssist heart pumps
Editor's Note The Food and Drug Administration (FDA), on June 5, identified the recall by Abiomed of specific Impella 5.5 with SmartAssist heart pumps as Class I, the most serious. The recall was initiated because of fluid leaking from the purge sidearm of the pump. If the leak issue is…
FDA: Class I recall of certain SD BioSensor Pilot COVID-19 At-Home Tests
Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…
FDA: Class I recall of Draeger Medical’s Seattle PAP Plus, breathing circuit/anesthesia kits
Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…
FDA: Class I recall of certain ICU Medical infusion system batteries
Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…
ECRI announces 2023 Alerts Impact Award winners
Editor's Note ECRI, on May 18, announced the winners of its annual 2023 Alerts Impact Award. The Award is given to members of ECRI’s Alerts Workflow system for excellence in recall management. The system’s software is used by supply chain, clinical engineering, IT, pharmacy, lab, clinical departments, and ancillary-care points…
FDA: Class I recall of certain Philips Respironics reworked DreamStation CPAP, BiPAP machines
Editor's Note The Food and Drug Administration, on April 7, identified the recall by Philips Respironics of certain reworked DreamStation continuous positive airway pressure (CPAP) and bileveled positive airway pressure (BiPAP) machines as Class I, the most serious. These machines also were recalled in June 2021. The recall was initiated…
Datascope/Getinge expands recall of certain IABPs for risk of unexpected shutdown after PCBA communication loss
Editor's Note The Food and Drug Administration (FDA) on March 31 identified the recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) for risk of unexpected shutdown after PCBA communication loss as Class I, the most serious. On March 17, the FDA also identified Datascope/Getinge’s recall…
FDA: Class I recall of certain Datascope/Getinge IABPs
Editor's Note The Food and Drug Administration (FDA) on March 17 identified the recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the coiled cable connecting the display and base on some units may fail,…
FDA: Class I recall of certain Philips Respironics ventilators
Editor's Note The Food and Drug Administration (FDA) on February 16 identified the recall by Philips Respironics of certain reworked Trilogy 100, Trilogy 200, and Garbin Plus ventilators as Class I, the most serious. The recall was initiated because of the potential for silicone foam adhesive failure and residual polyester-based…
FDA: Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems
Editor's Note The Food and Drug Administration (FDA) on February 15 identified the recall by GE HealthCare of its Nuclear Medicine 600/800 Series systems as Class I, the most serious. The recall was initiated because of an issue with two mechanisms that prevent uncontrolled detector movement. If the mechanisms fail,…
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