FDA Recall Open, Classified

SofTech Pressure-Sensing Wheelchair Cushions

Recall: Z-2594-2023 · Initiated July 6, 2023

Recall

Recall Number
Z-2594-2023
Event Number
92790
Firm
Aquila Corporation
FEI Number
3007066639
Product Code
KNN
Status
Open, Classified
Root Cause
Nonconforming Material/Component
Initiated
July 6, 2023
Posted
September 18, 2023
Address
3827 Creekside Ln, Holmen, WI, 54636-9466

Description

SofTech Pressure-Sensing Wheelchair Cushions

Reason

Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.

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].

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK

Quantity

134 units