FDA Recall
Terminated
klinoPORT, AC powered Operating Table
Recall: Z-0802-2011
·
Initiated October 26, 2010
Recall
- Recall Number
- Z-0802-2011
- Event Number
- 57209
- Firm
- Kreuzer Gmbh & Co. KG BenzstraBe 26 Puchheim Germany
- FEI Number
- 1000182014
- Product Code
- FQO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 26, 2010
- Posted
- December 22, 2010
- Terminated
- March 20, 2012
Description
klinoPORT, AC powered Operating Table
Reason
The motorized adjustable pendant arm may suddenly descend to its lowest position.
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.
Distribution
Nationwide Distribution -- CT, MA, and MO.
Quantity
15 units