Recall Z-2626-2017 ยท IKX Aid, Transfer
EOS Imaging
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
| Date | May 30, 2017 |
| Status | Terminated |
| Reason | ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin. |
| Root cause | Error in labeling |
| Action | EOS Imaging sent Field Safety Notice letter and Removal Instructions May 30, 2017. Customers are to immediately discontinue use of the grab handles and remove them from all affected units from inventory and return to a EOS Imaging. For further questions please call (678) 564-5400. |
| Quantity | 8 units each |
| Distribution | US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.