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U.S. Department of Health and Human Services

Class 2 Device Recall Permobil M3 Corpus Power Wheelchair

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 Class 2 Device Recall Permobil M3 Corpus Power Wheelchairsee related information
Date Initiated by FirmFebruary 29, 2024
Date PostedJuly 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2795-2026
Recall Event ID 99315
510(K)NumberK123290 
Product Classification Wheelchair, powered - Product Code ITI
ProductPermobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3
Code Information All Units operating with firmware version 1.26.2/UDI:(01)17330818345674
FEI Number 1221084
Recalling Firm/
Manufacturer		 Permobil Inc
300 Duke Dr
Lebanon TN 37090-8115
For Additional Information ContactDavid Rider
615-547-1890
Manufacturer 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,
FDA Determined
Cause 2		Process 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 complete. 4.If you have any questions or concerns, please contact the Permobil Customer Experience team at (800) 736-0925.
Quantity in Commerce140 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.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = ITI
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