Device product
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Z-0354-2024
Product summary
- Event
- Event 93303
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0354-2024
Official wording
Reason: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Code information: 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
Distribution pattern: International distribution to the countries of S. Korea and Turkey.
Derived failure modes
-
Unknown
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.