Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2805-2026Class II

M5 Corpus Power Wheelchair REF,120032

Permobil, AB / initiated 2025-06-19 / Open, Classified / root cause: manufacturing process

Permobil Inc began a recall of M5 Corpus Power Wheelchair REF,120032 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2805-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Permobil, AB
Product
M5 Corpus Power Wheelchair REF,120032
Product code
ITI Wheelchair, Powered
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.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
Power Platform firmware versions 1.27 through 1.57 UDI-DI 17330818334562

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2805-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2805-2026Class IIOngoingVoluntary: Firm initiated