14
Jun
2023

FDA Recall: Incorrect Compliance to Standards with IFU Software Update

0

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 Corp.

VOLUME OF PRODUCT IN COMMERCE:

4 units

DISTRIBUTION:

International distribution in the country of Germany.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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