![]() The target date for deploying this software, which will require FDA approval, is early 2020. Maquet/Datascope will schedule a training visit with every affected customer to discuss new guidance on conserving battery power and is also developing battery maintenance software. The recall, which the FDA identified yesterday as Class I, affects all lots and manufacturing and distribution dates for the following IABP models: Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS100/100i. Maquet/Datascope has received reports of five patient deaths since March 2016, but the company “has not concluded that the deaths are due solely to the device shutting down while operating on battery power,” according an alert from the US Food and Drug Administration. Getinge is recalling numerous Maquet/Datascope intra-aortic balloon pumps (IABPs) due to potential battery failure during use that can lead to unexpected stopping and shortened run times. ![]()
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