Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2795-2026Class II

Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3

Permobil, AB / initiated 2024-02-29 / Open, Classified / root cause: manufacturing process

Permobil Inc began a recall of Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3 on . FDA classified it as Class II and gives the reason as "This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2795-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Permobil, AB
Product
Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
Product code
ITI Wheelchair, Powered
Reason for recall
This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On March 5, 2024, Permobil issued a recall notification to affected consignees via Email. Permobil ask consignees to take the following actions: 1. Do not use the wheelchair when the firmware update is in process. The update is available now and will be proactively sent to the impacted wheelchairs within 1 week. 2. The provider will maintain possession of teh power wheelchair to ensure that the update has successfully installed prior to leaving it with the end user. 3. If not possible, the user should be notified about the pending reported update and instructed to allow this update to complete. 4.If you have any questions or concerns, please contact the Permobil Customer Experience team at (800) 736-0925.
Quantity in commerce
140 units
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 CAN.
Product codes and lots
All Units operating with firmware version 1.26.2/UDI:(01)17330818345674

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2795-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2795-2026Class IIOngoingVoluntary: Firm initiated