Recall Z-0802-2019 ยท IKZ Bed, Patient Rotation, Powered
Arjohuntleigh Magog
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
| Date | Feb 5, 2019 (initiated Dec 19, 2018) |
| Status | Terminated |
| Reason | Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event. |
| Root cause | Component design/selection |
| Action | Arjo hand-delivered the notice with each RotoProne Therapy System rental and delivery beginning on 12/19/2018. Arjo will require the customer to confirm the notification has been received and understood via the signed delivery notification. |
| Quantity | 231 units |
| Distribution | US, Saudi Arabia, and Kuwait |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.