Invacare Aquatec Fixed Backrest Recalled for Structural Failure Risk
Invacare is recalling 465 Aquatec Fixed Backrests because they may detach from the frame under uneven load, posing a risk of injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where the component may detach, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury risk, warranting a Severe classification.
Plain-English summary
Invacare Corporation is recalling 465 units of the Aquatec Fixed Backrest, an accessory for the Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP, and Ocean E-VIP family. The recall was initiated because the backrest withstands a load of only 250 newtons at uneven load, which may result in the Fixed Backrest becoming detached from the frame.
The affected units were distributed in Pennsylvania and Canada. The specific models involved are the Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793), and Ocean E-VIP (Model # 1525707). The source text does not specify the exact date of the recall or the specific actions consumers should take beyond the identification of the defect.
The recalled product
- Product
- Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
- Manufacturer
- Invacare Corporation
- Category
- Medical Device — Mobility Aids
- Affected units
- 465
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 (2)
- Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327)
- Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).
Distribution
Distributed in 1 state:
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