Derived label

Device software or design

Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: cybersecurity vulnerabilities
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Datascope Corp.