Restore Clinician Programmer Application Software recall: Software Issue
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Why was Restore Clinician Programmer Application Software 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 1.0.4232, UDI-DI 00763000273668.
- Product
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 2,408 devices
- Distribution
- Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)