Events

Recall of Maquet Magnus Carbonfibre table top

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet 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
    58789
  • Event Risk Class
    Class 2
  • Event Number
    Z-2238-2011
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2011-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100300
  • 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, radiologic - Product Code KXJ
  • Reason
    Maquet gmbh's quality monitoring detected that incorrect cover sheets were installed with some magnus carbon fibre table tops.
  • Action
    Maquet sent an Urgent Medical Device Corrective Action letter dated 4/15/2011, along with a Action Response Form, via Federal Express to their three customers informing them the incorrect cover sheets were installed with some of the affected "MAGNUS 1180.16F0 carbon-fibre table tops." The firm will have a Service Technician contact you to service the OR table, and will be exchanging the cover sheet free of charge. To the customers, please follow the instructions on the response form. At this time there have been no reports that injury has occurred. If you have additional questions, please contact yur local MAQUET Customer Service at 1-888-627-8383

Device

Maquet Magnus Carbonfibre table top
  • Model / Serial
    Article 1180.16F0, serial number 00004 Article 1180.16F2, serial number 00001 and 00002
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    LA, MO, VA
  • Product Description
    Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) || The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Manufacturer Address
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA