Events

Recall of Device Recall ORBIT PT

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

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
    66587
  • Event Risk Class
    Class 3
  • Event Number
    Z-0155-2014
  • Event Initiated Date
    2013-07-24
  • Event Date Posted
    2013-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122656
  • 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, ac-powered - Product Code JEA
  • Reason
    An odor and smoke developed - the cause was determined to be a power supply unit sitting in the controller column.
  • Action
    The user facility was contacted via phone in early August. They were contacted 9/17/2013 to schedule the replacement of the power pack because the new power pack became available.

Device

Device Recall ORBIT PT
  • Model / Serial
    Item No. 1275499, Serial No. 100711351
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: NJ only.
  • Product Description
    ORBIT PT. || The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
  • Manufacturer
    Trumpf Medical Systems

Manufacturer

Trumpf Medical Systems
  • Manufacturer Address
    Trumpf Medical Systems, 1046 Legrand Blvd, Charleston SC 29492-7672
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA