Recall Z-0167-2014 ยท INN Chair, Adjustable, Mechanical
Invacare Corporation
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
| Date | Nov 5, 2013 (initiated Aug 31, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Invacare sent an Urgent Medical Device Recall Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge their receipt and understanding of the urgent recall notice and indicate the number of affected product in their inventory on the enclosed Provider Response Card. Customers were instructed to examine their existing stock and quarantine any affected product and fax the completed Provider Response Card immediately to Invacare Corporation at 440-326-3544. Customers were re |
| Quantity | 538 (US only) 3317 (Total) |
| Distribution | Worldwide Distribution - USA including PA and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.