Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0802-2011

klinoPORT, AC powered Operating Table

Baxter Medical Systems GmbH + Co. KG / initiated 2010-10-26 / Terminated

Kreuzer Gmbh & Co. KG began a recall of klinoPORT, AC powered Operating Table on . The reason FDA records is "The motorized adjustable pendant arm may suddenly descend to its lowest position". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0802-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Medical Systems GmbH + Co. KG
Product
klinoPORT, AC powered Operating Table
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
The motorized adjustable pendant arm may suddenly descend to its lowest position.
FDA 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 in commerce
15 units
Distribution
Nationwide Distribution -- CT, MA, and MO.
Product codes and lots
Model number: klinoPORT 706, 806, 906, 1006 and 1306, Serial number between: 101039290 and 101158669