Device product
Cardiosave Hybrid 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 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Z-1506-2021
Product summary
- Firm
- Datascope Corp.
- Event
- Event 87482
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 10087 total
- Official record key
device-enforcement:Z-1506-2021
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: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432
Distribution pattern: Worldwide distribution - US Nationwide distribution.
Derived failure modes
-
Device software or design
cybersecurity vulnerabilities