ClearanceBrief
Recall Z-2795-2026 ยท ITI Wheelchair, Powered

Permobil Inc

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

DateJul 24, 2026 (initiated Feb 29, 2024)
StatusOpen, Classified
ReasonThis 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 causeProcess control
ActionOn 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 co
Quantity140 units
DistributionWorldwide - 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K123290M300 & M400
Permobil AB, Apr 17, 2013