Drug recall
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model…
FDA recall event 87569 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 87569 |
|---|---|
| Recall numbers | Z-1368-2021 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* *… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the… |
| Initiation date | Mar 9, 2021 |
| Report date | Apr 14, 2021 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2182207 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: