Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Reason for recall: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. Distribution: Worldwide - US Nationwide distribution. Quantity: 7123 Lot/code info: version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.
00763000520083
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.