Events

Recall of Device Recall Trumpf Medical Sysems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The OR Group.

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
    27655
  • Event Risk Class
    Class 2
  • Event Number
    Z-0184-04
  • Event Initiated Date
    2003-11-06
  • Event Date Posted
    2003-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30298
  • 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
    Board, Bed - Product Code FPS
  • Reason
    Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb.
  • Action
    The OR Group forwarded by 2nd day mail on 11/6/03 the repair kit and instructions to the accounts.

Device

Device Recall Trumpf Medical Sysems
  • Model / Serial
    Serial Number: 192478
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. CA, FL, GA, IA MI, MT, NH, OH, NJ, NY, SC, UT, TX, VA
  • Product Description
    Trumpf Universal Imaging Extension (OEM) || Catalog NUmber: F-PMT-A2
  • Manufacturer
    The OR Group

Manufacturer

The OR Group
  • Manufacturer Address
    The OR Group, 531 Main St, Acton MA 01720-3934
  • Source
    USFDA