A901 Communication Manager Application recall: Software Issue
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Why was A901 Communication Manager Application recalled?
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
- Product
- A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 2 clinician tablets
- Distribution
- International distribution to the countries of Israel and Serbia.
- Recall date
- August 2, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)