Recall Z-0802-2011 ยท FQO Table, Operating-Room, Ac-Powered
Kreuzer Gmbh & Co. KG
klinoPORT, AC powered Operating Table
| Date | Dec 22, 2010 (initiated Oct 26, 2010) |
| Status | Terminated |
| Reason | The motorized adjustable pendant arm may suddenly descend to its lowest position. |
| Root cause | Other |
| Action | Consignees were notified by a Warning Notice on/about 10/26/2010. Medical facilities were instructed to adjust the pendant arm to the lowest height position and disable the motor and to place the accompanying warning label on the pendant. They will, therefore, not be able to adjust the height of the pendant until corrective action is developed and completed. TRUMPF Medical Systems, Inc. will receive corrective action repair kits by 11/12/2010. |
| Quantity | 15 units |
| Distribution | Nationwide Distribution -- CT, MA, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.