Recall Z-2023-2014 ยท INN Chair, Adjustable, Mechanical
Invacare Corporation
Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
| Date | Jul 9, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing. |
| Quantity | 465 units |
| Distribution | Distributed in PA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.