Recall Z-0342-2014 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Trumpf Medical Systems, Inc.
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia.
| Date | Nov 18, 2013 (initiated Oct 28, 2013) |
| Status | Terminated |
| Reason | The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame. |
| Root cause | Packaging |
| Action | TRUMPF sent an Urgent Safety Information letter dated October 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to inspect Leg Section One Part Light for damage to the coupler point (hook) between each case. If any damage is noticed to the coupler, they were instructed to stop use immediately and contact TRUMPF Technical Service. If they drop or collide the Leg Section One Part Light into anything then stop use immediately and contact TRUMPF Technical Service. Review the User Instruc |
| Quantity | 15 components |
| Distribution | US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.