| | Class 2 Device Recall MS Corpus Power Wheelchair |  |
| Date Initiated by Firm | June 19, 2025 |
| Date Posted | July 24, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2805-2026 |
| Recall Event ID |
99267 |
| 510(K)Number | K123290 |
| Product Classification |
Wheelchair, powered - Product Code ITI
|
| Product | M5 Corpus Power Wheelchair REF,120032 |
| Code Information |
Power Platform firmware versions 1.27 through 1.57
UDI-DI 17330818334562 |
| FEI Number |
1221084
|
Recalling Firm/ Manufacturer |
Permobil Inc 300 Duke Dr Lebanon TN 37090-8115
|
| For Additional Information Contact | david Rider 615-547-1890 |
Manufacturer Reason for Recall | This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances. |
FDA Determined Cause 2 | Process design |
| Action | On June 10, 2025 Permobil issued a technical bulletin (recall notice) via Email to affected consignees. Permobil informed consignees of the following:
1. Cellular connection is required to receive and install the firmware update.
2. It is important to not use the wheelchair when the firmware update is in process (as indicated on the display of the input device).
3. Specific Remote Update Instructions are available if needed in addition to the on-screen information.
4. A confirmation of the completed update will be shown on the joystick display when the update successfully completes.
5. If you have any questions or concerns, please contact the Permobil Customer Experience team at (800) 736-0925.
1. |
| Quantity in Commerce | 715 wheelchairs |
| Distribution | Worldwide - US: Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CANADA. |
| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = ITI
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