Events

Recall of Device Recall Titan

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
    60440
  • Event Risk Class
    Class 2
  • Event Number
    Z-0398-2012
  • Event Initiated Date
    2011-01-21
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105409
  • 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, operating-room, ac-powered - Product Code FQO
  • Reason
    Product is being recalled due to unintended movement on the titan tables.
  • Action
    Trumpf Medical Systems sent an initial notification to customers dated January 24, 2011. A subsequent "URGENT SAFETY NOTICE-UPDATE" letter dated May 26, 2011 was sent to all affected customers. The letter described the product, problem, and actions to be taken by the customers. A Corrective Action Plan includes a software update to be installed by a Trumpf Technical Service Representative. Contact Technical Service at 888-474-9359 for questions regarding this notice.

Device

Device Recall Titan
  • Model / Serial
    Material number 1465166, All Serial numbers.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    OR table TITAN UT, Surgical Table. || Surgical bed with Orthopedic Accessories.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

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