Summary
The FDA issued a Class II for SofTech Pressure-Sensing Wheelchair Cushions by Aquila Corporation. Reason: Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury..
Details
Source
Device Recall
External ID
Z-2594-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
SofTech Pressure-Sensing Wheelchair Cushions
Lot/Code Info: 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
Quantity Affected: 134 units
Reason for Recall
Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Sweden, Romania, Australia, UK
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-06
Company
Holmen, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aquila Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aquila Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aquila Corporation have FDA actions?
Aquila Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2594-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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