Recall Z-0155-2014
Trumpf Medical Systems · initiated July 24, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
Codes / lots: Item No. 1275499, Serial No. 100711351
Reason for recall
An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0155-2014
- Initiated
- July 24, 2013
- Posted by FDA
- November 5, 2013
- Terminated
- June 3, 2014
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Quantity
- One
- Distribution
- US Distribution: NJ only.
- Recalling firm
- Trumpf Medical Systems, Charleston, SC