LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop
LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.
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Search Results for: recall
Getinge Subsidiary Recalls Intra-Aortic Balloon Pumps Due to Compromised Materials
Getinge is recalling IABP devices due to a compromised intra-aortic balloon causing blood to enter the IABP during therapy.
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Healthcare Workers File Petition Asking FDA to Recall Fresenius Dialysis Machines
A petition was submitted to the FDA to issue a corrective recall requiring modifications to dialysis machines manufactured by Fresenius.
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Gaps in Recalls of Home Medical Devices Top ECRI’s Hazards List
ECRI has named gaps with recalls of home-use medical devices as the nation’s most pressing health technology safety issue for 2023.
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Rethinking 510(k): Studies Show Risk of Using Recalled Devices as Predicates for FDA Clearance
New studies detailed how stronger safeguards are needed to prevent problematic predicate selection of medical devices.
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