Events

Recall of 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 Medical Systems, Usa.

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
    62590
  • Event Risk Class
    Class 2
  • Event Number
    Z-2108-2012
  • Event Initiated Date
    2012-04-13
  • Event Date Posted
    2012-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111138
  • 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
    As a result of a small number of customer complaints, maquet conducted an investigation and identified a potential problem with specific magnus carbon-fibre table tops manufactured between february 23, 2010 and february 28, 2012 and distributed between november 11, 2010 and april 6, 2012. there is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.
  • Action
    MAQUET GETINGE Group sent An "Urgent Device Field Correction" notification, dated 13 April 2012 via Federal Express to all affected customers. An acknowledgement form is included with the customer letter which can be mailed or faxed back to Maquet Quality by the notified customers. If the completed Acknowledgement form is not received within 15 days, up to three follow ups will be made and documented via telephone call to each customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and notify their MAQUET Service Representative immediately. The MAQUET Service Representative will contact customers to make arrangements to replace both te logitudinal shift and tilt drives of their table top(s). For questions customers should call 888-627-8383, press option 2, followed by option 1. For questions regarding this recall call 201-995-8968.

Device

Magnus CarbonFibre Table Top
  • Model / Serial
    Model # 1180.16F2 Serial #s 1,3,7, & 8; Model # 1180.16F3 Serial # 1; Model #1180.16F5 Serial #4; Model # T285.7000 Serial #s 1,2,3,4, & 7.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand.
  • Product Description
    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 || The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
  • Manufacturer
    Maquet Medical Systems, Usa

Manufacturer

Maquet Medical Systems, Usa
  • Manufacturer Address
    Maquet Medical Systems, Usa, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA