Z-2594-2023Class II

SofTech Pressure-Sensing Wheelchair Cushions

Name: Z-2594-2023 SofTech Pressure-Sensing Wheelchair Cushions
Creator: Aquila Corporation
Published: 2023-07-06
License: https://open.fda.gov/license/

Aquila Corporation / initiated 2023-07-06 / Open, Classified / root cause: manufacturing process

FDA source

Aquila Corporation began a recall of SofTech Pressure-Sensing Wheelchair Cushions on 2023-07-06. FDA classified it as Class II and gives the reason as "Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2594-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-06
Posted: 2023-09-18
Recalling firm: Aquila Corporation
Product: SofTech Pressure-Sensing Wheelchair Cushions
Product code: KNN Components, Wheelchair
Reason for recall: Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
Root cause tag: manufacturing process
FDA 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 [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].
Quantity in commerce: 134 units
Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2594-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2593-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2594-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18

Product code KNN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)