Device product
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
Z-1507-2021
Product summary
- Firm
- Datascope Corp.
- Event
- Event 87482
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 10087 total
- Official record key
device-enforcement:Z-1507-2021
Official wording
Reason: There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Code information: All Systems. UDI: 10607567112312 10607567108407 10607567113449
Distribution pattern: Worldwide distribution - US Nationwide distribution.
Derived failure modes
-
Device software or design
cybersecurity vulnerabilities