TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to re

FDA device recall Z-0141-2015 · posted 2014-10-27 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

Reason for recall

Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.

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.

Root cause

Device Design

Status

Terminated

Product code

JEA

Quantity affected

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 C

Date initiated

2014-10-09

Date posted

2014-10-27

Date terminated

2016-03-23

Location

Charleston, SC