PushTracker E2 component utilized with the SmartDrive MX2+ Power… — Class II medical device recall Z-2004-2023
Ongoing recall by Permobil, reported 2023-07-05. When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail une
| Recall number | Z-2004-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Permobil, Lebanon, TN, United States |
| Recall initiated | 2023-05-10 |
| Classified | 2023-06-26 |
| Reported by FDA | 2023-07-05 |
| Quantity | 18,905 units |
| Reason classes | device malfunction |
| Model numbers | MX2-150, MX2-167, MX2-32D, MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S |
Product
PushTracker E2 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
Reason for recall
When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2004-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.