Z-2657-2023 Class II Terminated
FDA device recall Z-2657-2023 was initiated by Medtronic Neuromodulation on Jul 17, 2020 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Sep 27, 2024). Affected quantity: 2,408 devices.
Recall details
- Product Type
- Devices
- Report Date
- Oct 11, 2023
- Initiation Date
- Jul 17, 2020
- Termination Date
- Sep 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,408 devices
Product description
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Reason for recall
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.
Distribution pattern
Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Code information
Version 1.0.4232, UDI-DI 00763000273668.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2657-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026