Device 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.
Z-0141-2015
Product summary
- Event
- Event 69426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 184 units
- Official record key
device-enforcement:Z-0141-2015
Official wording
Reason: Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.
Code information: TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.