Events

Recall of klinoPORT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kreuzer Gmbh & Co. KG.

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
    57209
  • Event Risk Class
    Class 2
  • Event Number
    Z-0802-2011
  • Event Initiated Date
    2010-10-26
  • Event Date Posted
    2010-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95602
  • 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
    Ac-Powered Operating-Room Table - Product Code FQO
  • Reason
    The motorized adjustable pendant arm may suddenly descend to its lowest position.
  • Action
    Consignees were notified by a Warning Notice on/about 10/26/2010. Medical facilities were instructed to adjust the pendant arm to the lowest height position and disable the motor and to place the accompanying warning label on the pendant. They will, therefore, not be able to adjust the height of the pendant until corrective action is developed and completed. TRUMPF Medical Systems, Inc. will receive corrective action repair kits by 11/12/2010.

Device

klinoPORT
  • Model / Serial
    Model number: klinoPORT 706, 806, 906, 1006 and 1306, Serial number between: 101039290 and 101158669
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- CT, MA, and MO.
  • Product Description
    klinoPORT, AC powered Operating Table
  • Manufacturer
    Kreuzer Gmbh & Co. KG

Manufacturer

Kreuzer Gmbh & Co. KG
  • Manufacturer Address
    Kreuzer Gmbh & Co. KG, BenzstraBe 26, Puchheim Germany
  • Source
    USFDA