TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted on

FDA device recall Z-0342-2014 · posted 2013-11-18 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

Reason for recall

The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.

Action taken

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 Instruction for proper use and care of the device. The leg section should be used only as intended as part of the TRUMPF TS7000 surgical table. The intended use is to support and position the patients legs during the pre-operative and post-operative stages of surgery. The leg section should be removed during surgery. TRUMPF will be exchanging the hooks, counter plates and screws of the coupler point to increase the area that the load is distributed over. This will allow the screws securing the hood to the leg frame to withstand external forces. TRUMPF anticipates parts to be available the first week of November. TRUMPF trained technicians will complete the TRUMPF Medical Systems, Inc. for the part exchange. Completion is anticipated by November 11, 2013. Further questions please call (843) 534-0606

Root cause

Packaging

Status

Terminated

Product code

JEB

Quantity affected

15 components

Distribution

US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.

Date initiated

2013-10-28

Date posted

2013-11-18

Date terminated

2014-09-16

Location

Charleston, SC