Recall Z-2023-2014— Invacare Corporation
Class II · Terminated
Class II FDA medical device recall by Invacare Corporation, initiated 2014-06-25, terminated 2015-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.. Reason: The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame..
- Recalling firm
- Invacare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-25
- Terminated
- 2015-04-15
- Firm location
- Elyria, OH, United States
Product description
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Reason for recall
The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.
Data sourced from openFDA. This site is unofficial and independent of the FDA.