Day

June 14, 2023
14
Jun

FDA Recall: Software Update Incorrectly Annotated Compliance to Standard

June 14, 2023
Company: Datascope Corp. Date of Enforcement Report: 06/14/2023 Class III PRODUCT Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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14
Jun

FDA Recall: Incorrect Compliance to Standards with IFU Software Update

June 14, 2023
Company: Datascope Corp. Date of Enforcement Report: 6/14/2023 Class III PRODUCT: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...
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