Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0398-2012

OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories

Hill-Rom Inc. / initiated 2011-01-21 / Terminated / root cause: design

Trumpf Medical Systems, Inc. began a recall of OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories on . The reason FDA records is "Product is being recalled due to unintended movement on the Titan Tables". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0398-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
OR table TITAN UT, Surgical Table. Surgical bed with Orthopedic Accessories.
Product code
FQO Table, Operating-Room, Ac-Powered
Reason for recall
Product is being recalled due to unintended movement on the Titan Tables.
Root cause tag
design
FDA root cause
Device Design
Action
Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.
Quantity in commerce
see line 1.
Distribution
Worldwide Distribution.
Product codes and lots
Material number 1465166, All Serial numbers.