Recall Z-2594-2023 ยท KNN Components, Wheelchair
Aquila Corporation
SofTech Pressure-Sensing Wheelchair Cushions
| Date | Sep 18, 2023 (initiated Jul 6, 2023) |
| Status | Open, Classified |
| Reason | Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury. |
| Root cause | Nonconforming Material/Component |
| 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 aquilarc23@gmail.com to receive your RMA#. Remove the fabric coverings from your SofTech Cushion or APK2 |
| Quantity | 134 units |
| Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.