Recall Z-0141-2015
Trumpf Medical Systems, Inc. · initiated October 9, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Codes / lots: TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.
Reason for recall
Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.
FDA-determined cause: Device Design
Action taken
TRUMPF sent an Urgent Medical Device Correction letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Complete and return the attached Confirmation of Receipt form with serial numbers of the TITAN table(s) and the serial number(s) for any remote controls you have. We will then arrange to send replacement remotes, which have been redesigned to eliminate this mode of failure. You will then be required to dispose of your recalled remotes. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359.
Details
- Recall number
- Z-0141-2015
- Initiated
- October 9, 2014
- Posted by FDA
- October 27, 2014
- Terminated
- March 23, 2016
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Quantity
- 184 units
- Distribution
- Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.
- Recalling firm
- Trumpf Medical Systems, Inc., Charleston, SC