Device recall
Z-2005-2023: PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device…
FDA device recall · Class II · Permobil
Key facts
| Recall number (Z-number) | Z-2005-2023 |
|---|---|
| Recall event | 92250 |
| Product | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application |
| Product code | ITI |
| Recalling firm | Permobil |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K151199 |
| FEI number | 3008370857 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database