Events

Recall of FIXTURE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    134122
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The fixture (1002.65a0) is designed as a connecting element for the support and positioning of the patient's head on a maquet or table immediately before during and after surgical interventions as well as for examination and treatment. the fixture is used to adapt a range of different head rests and horseshoe head rests with a central square mount. as part of post market surveillance cases have been reported to maquet gmbh which showed the welded joint between square mount and the first fixable swivel joint broke. this joint must bear the highest loads of all welded joints due to the cantilever. it is likely that the breakage had been caused by a poor welding joint in addition to rough handling and multiple overload by the user respectively. if the weld seam breaks during a procedure a serious injury cannot be ruled out.

Device

FIXTURE
  • Model / Serial
    Model Catalog: 1002.65A0 (Lot serial: NA)
  • Product Description
    Fixture 1002.65A0
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC