Events

Recall of Magnus Hybrid operating table columns

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
    60344
  • Event Risk Class
    Class 2
  • Event Number
    Z-0389-2012
  • Event Initiated Date
    2011-09-19
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105069
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Table, operating room, ac powered - Product Code LFQO
  • Reason
    A component of the magnus hybrid or system fails to respond to a position command.
  • Action
    Maquet sent a PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION letter dated September 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. To avoid the potential of a malfunction occurring prior to their scheduled Service procedure, customers were instructed to ensure that the MAGNUS table-top is positioned at the "0" pivot position and that the MAGNUS column pivot brake is secured. If it is necessary to pivot the MAGNUS table-top prior to procedure start, ensure that the column pivot brake is completely released and then completely secured when returned to "0" pivot position. Customers were instructed to ensure that all user of the affected product and other necessary persons are informed of the product correction notice. For technical support or questions call 1-888-627-8383

Device

Magnus Hybrid operating table columns
  • Model / Serial
    510 k EXEMPT  1180.01A1- Lot #0002, 0004, 0005, 0007-00011, 00013- 0017, 00019-00029, 00001  1180.01B1- lOT #00001, 00002, 00005-00012, 00014, 00015, 00017, 00018
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES, IE, IL, SP, PL, RU, and TH.
  • Product Description
    Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
  • 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