Events

Recall of Device Recall Maquet Medical Systems

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
    69560
  • Event Risk Class
    Class 2
  • Event Number
    Z-0993-2015
  • Event Initiated Date
    2014-08-21
  • Event Date Posted
    2015-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130952
  • 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
    Medical device data system - Product Code OUG
  • Reason
    The wrong movement results on the magnus or table. the button commands on the tegris touchscreen for lower leg up and upper leg down are switched in the software for the integration with the magnus operating table system.
  • Action
    Maquet sent an Urgent Medical Device Field Correction Letter dated August 21, 2014, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following measures until the issue is corrected: The TEGRIS equipped with a software module version up to 2.1.X.X should not be used in conjunction wiht a MAGNUS operating table system. All other MAQUET operating tables are not affected. A MAQUET service representative would contact them and arrange to have their TEGRIS software module updated. Customers with questions were instructed to contact MAQUET Technical Support at 1-888-627-8383 (press option 3, followed by option 1, then option 1 again. For questions regarding this recall call 973-709-7000.

Device

Device Recall Maquet Medical Systems
  • Model / Serial
    part number: 1703.35AO, with software version up to 2.1.x.x.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including NE, NY and PA.
  • Product Description
    TEGRIS System manufactured by MAQUET GMBH in Germany || The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.
  • 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