Percept PC Implantable Neurostimulator recall: Software Issue
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is…
Why was Percept PC Implantable Neurostimulator recalled?
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
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?
Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
- Product
- Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is…
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 12 devices
- Distribution
- US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)