Agency classClass IIOur severity:High FDA (Devices)·Z-2594-2023·Announced 2023-09-27

SofTech Wheelchair Cushions Recalled for Defective Battery Overheating Risk

Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions with defective battery packs that can overheat, risking property damage and a possible injury. The affected units have been distributed nationwide in the US and internationally to Canada, Sweden, Romania, Australia, and the UK.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA recall for a pressure-sensing medical device with a defective battery that can overheat. Property damage is a stated potential consequence, and one possible injury is noted. Without confirmed reports of actual injury or illness, this qualifies as a risk-of-harm product per the rubric.

Plain-English summary

Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions containing defective battery packs. The battery packs can overheat, creating a risk of property damage and possible injury to users.

The defect affects specific serial numbers of the product. Consumers with affected units should not use the wheelchair cushions.

The recalled cushions have been distributed worldwide, including throughout the United States (nationwide), Canada, Sweden, Romania, Australia, and the United Kingdom. All 134 affected units are included in this recall.

Consumers who own an affected cushion should immediately stop using the device and contact Aquila Corporation regarding replacement or repair options. Reference the product's serial number when contacting the manufacturer.

The recalled product

Product: SofTech Pressure-Sensing Wheelchair Cushions
Manufacturer: Aquila Corporation
Category: Medical Device — Wheelchair Cushion
Hazard: battery-overheating
property-damage
Affected units: 134

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: 4441
4541
5064
5681
6012
6078
6342
6487
6547
6835
6844
6859
6869
6976
6985
6989
6990
6994
6995
6996

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Aquila Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Aquila Corporation

See all →

High
APK2 Wheelchair Cushion Battery Pack Defect Can Cause Overheating
FDA (Devices) · 2023-09-27

Same hazard · battery overheating