Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Reported: October 11, 2023 Initiated: July 17, 2020 #Z-2657-2023
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 2,408 devices
- Distribution
- Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.. Recalled by Medtronic Neuromodulation. Units affected: 2,408 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-2657-2023.
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