APK2 Pressure-Sensing Wheelchair Cushions
FDA Recall Z-2593-2023 · Posted 2023-09-18
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Recalling FirmAquila Corporation
Recall StatusOpen, Classified
Product CodeKNN
Date Initiated2023-07-06
Product Quantity117 units
Reason for Recall
Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
Firm Action
Aquila Corporation issued a "Product Safety-Corrective Action URGENT NOTICE" on 07/27/2023 via email and USPS first class mail. The notice explained the problem, the risk to the user, and to cease use of the affected product. The firm is seeking return of the products. Options also include: 1) modifying the device to run off of a powered wheelchair using instructions to be provided by the firm or 2) exchange of the batteries.
Actions to be taken by the Dealer/Customer:
1. Email us at [email protected] to receive your RMA#. Remove the fabric coverings from your SofTech Cushion or APK2 Control Box.
2. Write the RMA# on the side of your box and return it to us at:
Aquila Corporation
3827 Creekside Lane
Holmen, WI 54636
3. Complete the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE letter and mail it to us at the above address, scan it and mail it to us at [email protected] or fax it to us at 1.608.782.0488. You may also complete it and include it in your package.
4. IF YOU WANT BATTERIES AS OPPOSED TO RUNNING OFF YOUR POWER WHEELCHAIR BATTERIES, PLEASE INDICATE THAT IN YOUR EMAIL WHEN YOU REQUEST YOUR RMA NUMBER.
If you have any questions, call 608-782-0031 or email: [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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