Z-0612-2021 Class II Terminated
FDA device recall Z-0612-2021 was initiated by Medtronic Neuromodulation on Nov 19, 2020 and is designated Class II. Reason for recall: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. The recall status is terminated (terminated Apr 3, 2023). Affected quantity: 12 devices.
Recall details
- Product Type
- Devices
- Report Date
- Dec 23, 2020
- Initiation Date
- Nov 19, 2020
- Termination Date
- Apr 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product description
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
Reason for recall
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Distribution pattern
US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Code information
Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0612-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026