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Terminated

klinoPORT, AC powered Operating Table

FDA Recall Z-0802-2011 · Posted 2010-12-22

Recalling FirmKreuzer Gmbh & Co. KG
Recall StatusTerminated
Product CodeFQO
Date Initiated2010-10-26
Date Terminated2012-03-20
Product Quantity15 units

Reason for Recall

The motorized adjustable pendant arm may suddenly descend to its lowest position.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution -- CT, MA, and MO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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