Z-1506-2021 Class III Ongoing
FDA device recall Z-1506-2021 was initiated by Datascope Corp. on March 22, 2021 and is designated Class III. Reason for recall: 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 (HI… The recall status is ongoing. Affected quantity: 10087 total.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10087 total
Product Description
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
Reason for Recall
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).
Distribution Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432