Events

Recall of MAQUET HANAULUX BLUE 130 SPRING ARM FOR BLUE SURGICAL LIGHT

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
    59634
  • Event Risk Class
    III
  • Event Initiated Date
    2009-09-23
  • 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
    There is potential for a crack on the front pivot of the acrobat 2000 spring arm installed with a blue 130 series surgical light that could cause the surgical light to swing freely. defect rate is 0.35%.

Device

MAQUET HANAULUX BLUE 130 SPRING ARM FOR BLUE SURGICAL LIGHT
  • Model / Serial
    Model Catalog: 56077943 (Lot serial: 00001717); Model Catalog: 56077943 (Lot serial: 00001719)
  • Product Description
    MAQUET HANAULUX MODEL BLUE 130
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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