Recall Z-2657-2023— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2020-07-17, terminated 2024-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.. 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-17
- Terminated
- 2024-09-27
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.