Events

Recall of TruSystem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trumpf Medical Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66688
  • Event Risk Class
    Class 2
  • Event Number
    Z-0342-2014
  • Event Initiated Date
    2013-10-28
  • Event Date Posted
    2013-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122967
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, surgical with orthopedic accessories, manual - Product Code JEB
  • Reason
    The coupler point (hood) of the leg section one part light may become detached from the leg section frame.
  • 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 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

Device

TruSystem
  • Model / Serial
    Item no. 1739993, All serial numbers.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
  • Product Description
    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. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Manufacturer Address
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492-7906
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA