Recall Z-0141-2015 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Trumpf Medical Systems, Inc.
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.
| Date | Oct 27, 2014 (initiated Oct 9, 2014) |
| Status | Terminated |
| Reason | Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes. |
| Root cause | Device Design |
| Action | 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 concernin |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.