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U.S. Department of Health and Human Services

Class 2 Device Recall Aquila

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  Class 2 Device Recall Aquila see related information
Date Initiated by Firm July 06, 2023
Date Posted September 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-2593-2023
Recall Event ID 92790
Product Classification Components, wheelchair - Product Code KNN
Product APK2 Pressure-Sensing Wheelchair Cushions
Code Information Serial Numbers: 3213, 3878, 4661, 4754, 5270, 5527, 5532, 5754, 5766, 5771, 5771, 5811, 5830, 5877, 5908, 6177, 6181, 6326, 6337, 6596, 6808, 6833, 6837, 6865, 6879, 6901, 6903, 6949, 6967, 6983, 6988, 6988, 6991, 6992, 6993, 6993, 6998, 6998, 6999, 6999, 7003, 7012, 7012, 7013, 7013, 7013, 7014, 7015, 7015, 7019, 7019, 7024, 7027, 7028, 7029, 7034, 7035, 7036, 7036, 7037, 7037, 7056, 7056, 7057, 7063, 7064, 7078, 7087, 7088, 7088, 7090, 7090, 7504, 7515, 7619, 7673, 7696, 7725, 7764, 7782, 7838, 7867, 7869, 7869, 7877, 7878, 7878, 7879, 7880, 7884, 7888, 7889, 7890, 7890, 7891, 7901, 7901, 7902, 7903, 7903, 7937, 7945, 7946, 7947, 7948, 7953, 7954, 7955, 7955, 7975, 7975, 7976, 7977, 7977, 7991, 7991, 7992
Recalling Firm/
Manufacturer		 Aquila Corporation
3827 Creekside Ln
Holmen WI 54636-9466
For Additional Information Contact MRS. JUSTINE KOHLMAN
608-782-0031
Manufacturer Reason
for Recall		 Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
FDA Determined
Cause 2		 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 in Commerce 117 units
Distribution Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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