Events

Recall of Device Recall MAQUET Extension Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular Us Sales, Llc.

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
    73212
  • Event Risk Class
    Class 2
  • Event Number
    Z-1045-2016
  • Event Initiated Date
    2016-01-07
  • Event Date Posted
    2016-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143578
  • 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
    Maquet medical systems usa is initiating a field action for correction of the maquet extension device (part no 1180.19f0). the extension device is manufactured by maquet gmbh, in germany, and is a table top module for use with the maquet magnus operating table system. maquet gmbh was made aware of a potential issue that can result in the extension device becoming unlocked from the table top, causing it to fall down.
  • Action
    Maquet sent "URGENT PRODUCT RECALL MEDICAL DEVICE CORRECTION" letters/MEDICAL DEVICE CORRECTION RESPONSE FORM dated January 7, 2016, via UPS to the affected customers. The notification informed customers of the issue with the affected product; how to identify affected product; measures to be taken by the users; and that a MAQUET service representative will be contacting them to schedule servicing of the device to install a Support Frame Lock. Customers with questions were asked to contact their local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Option 2, Option 3) Monday through Friday between 8:00 am and 5:00 pm EDT. Customers were also requested to fill out and return the attached response forms.

Device

Device Recall MAQUET Extension Device
  • Model / Serial
    Catalog Number 1180.19F0; Serial numbers 00003 and 00004.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including AZ and MO. Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, || Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA