Device product
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Z-2657-2023
Product summary
- Event
- Event 92798
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,408 devices
- Official record key
device-enforcement:Z-2657-2023
Official wording
Reason: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
Code information: Version 1.0.4232, UDI-DI 00763000273668.
Distribution pattern: Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Derived failure modes
-
Device software or design
issue with some legacy clinician programmer software