Medtronic Neuromodulation: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Hazard

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

Details from the source

Reason for recall: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. Distribution: International distribution to the countries of S. Korea and Turkey. Quantity: 26 units Lot/code info: UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N

UPC codes

00763000642297, 00763000724436

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.