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U.S. Department of Health and Human Services

Class 2 Device Recall MS Corpus Power Wheelchair

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 Class 2 Device Recall MS Corpus Power Wheelchairsee related information
Date Initiated by FirmJune 19, 2025
Date PostedJuly 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2805-2026
Recall Event ID 99267
510(K)NumberK123290 
Product Classification Wheelchair, powered - Product Code ITI
ProductM5 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 Contactdavid 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
ActionOn 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 Commerce715 wheelchairs
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 CANADA.
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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