APK2 Pressure-Sensing Wheelchair Cushions

FDA device recall Z-2593-2023 · posted 2023-09-18 · Open, Classified

Recall details

Recalling firm

Aquila Corporation

Reason for recall

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

Action taken

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 aquilarc23@gmail.com 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 aquilarc23@gmail.com 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: AQUILA@AQUILACORP.COM.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KNN

Quantity affected

117 units

Distribution

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

Date initiated

2023-07-06

Date posted

2023-09-18

Location

Holmen, WI