510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0155-2014Class III

ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient...

Hill-Rom Inc. / initiated 2013-07-24 / Terminated / root cause: design

Trumpf Medical Systems began a recall of ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process on . FDA classified it as Class III and gives the reason as "An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0155-2014
Classification
Class III
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
Product code
JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall
An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.
Root cause tag
design
FDA root cause
Component design/selection
Action
The user facility was contacted via phone in early August. They were contacted 9/17/2013 to schedule the replacement of the power pack because the new power pack became available.
Quantity in commerce
One
Distribution
US Distribution: NJ only.
Product codes and lots
Item No. 1275499, Serial No. 100711351

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0155-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0155-2014Class IIITerminatedVoluntary: Firm initiated