Device product
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Z-1043-2026
Product summary
- Event
- Event 98097
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7123
- Official record key
device-enforcement:Z-1043-2026
Official wording
Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Code information: version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.