Events

Recall of Connection Bracket

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
    53612
  • Event Risk Class
    Class 2
  • Event Number
    Z-0480-2010
  • Event Initiated Date
    2009-10-22
  • Event Date Posted
    2009-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86036
  • 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
    Operating-Room Table Accessories - Product Code FWZ
  • Reason
    Product monitoring has determined that the connection bracket shows potential mechanical play at the or table interface for some procedures. this is due to the hole in the lock washer, which is responsible for locking the accessory to the or table, being too large.
  • Action
    Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.

Device

Connection Bracket
  • Model / Serial
    No serial or lot numbers, just a catalogue number.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- USA, including states of SC and PA.
  • Product Description
    Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. || An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
  • 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