FDA Medical Device Recalls (openFDA)
Aquila Corporation: SofTech Pressure-Sensing Wheelchair Cushions
- Recall number
- Z-2594-2023
- Recalling firm
- Aquila Corporation
- Product
- SofTech Pressure-Sensing Wheelchair Cushions
- Status
- Open, Classified
- Initiated
- 2023-07-06
- Posted
- 2023-09-18
- Terminated
- not on file
- 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 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.
- Quantity
- 134 units
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK
- Lot, serial or model codes
- Serial Numbers: 4441, 4541, 5064, 5681, 6012, 6078, 6342, 6487, 6547, 6835, 6844, 6859, 6869, 6976, 6985, 6989, 6990, 6994, 6994, 6995, 6995, 6996, 6997, 7001, 7002, 7016, 7017, 7018, 7021, 7022, 7022, 7023, 7023, 7031, 7033, 7058, 7059, 7059, 7060, 7061, 7061, 7065, 7066, 7074, 7075, 7076, 7076, 7077, 7080, 7080, 7081, 7081, 7082, 7083, 7084, 7521, 7599, 7774, 7774, 7854, 7862, 7863, 7864, 7864, 7871, 7871, 7873, 7873, 7874, 7876, 7881, 7883, 7885, 7886, 7887, 7887, 7893, 7896, 7904, 7905, 7907, 7929, 7930, 7930, 7932, 7934, 7936, 7939, 7939, 7940, 7941, 7941, 7942, 7943, 7943, 7951, 7952, 7956, 7956, 7970, 7971, 7971, 7973, 7974, 7979, 7980, 7981, 7981, 7982, 7988, 7988, 7989, 7990, 7993, 7993, 7996, 7997, 7997, 7999, 8000, 8001, 8002, 8003, 8003, 8004, 8005, 8006, 8007, 8008, 8010, 8011, 8012, 8013, 8044
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNN
- Firm FEI
- 3007066639
- Firm city
- Holmen
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28