Summary
The FDA issued a Class II for M5 Corpus Power Wheelchair REF,120032 by Permobil Inc. Reason: This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive .
Details
Source
Device Recall
External ID
Z-2805-2026
Action Date
2026-08-05
Status
Ongoing
Category
device
Product Description
M5 Corpus Power Wheelchair REF,120032
Lot/Code Info: Power Platform firmware versions 1.27 through 1.57 UDI-DI 17330818334562
Quantity Affected: 715 wheelchairs
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-19
Company
Lebanon, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 device recalls issued in the same week, part of 341 device-related FDA actions this month.
Permobil Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Permobil Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Permobil Inc have FDA actions?
Permobil Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2805-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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