Recall Z-0167-2014— Invacare Corporation
Class II · Terminated
Class II FDA medical device recall by Invacare Corporation, initiated 2013-08-31, terminated 2014-09-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function. Reason: The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched..
- Recalling firm
- Invacare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-31
- Terminated
- 2014-09-15
- Firm location
- Elyria, OH, United States
Product description
Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function
Reason for recall
The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched.
Data sourced from openFDA. This site is unofficial and independent of the FDA.