Events

Recall of SPRING ARM FOR 3004 TV

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
    29827
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-02
  • 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
    Fissured or broken weld seams continue to be reported from the field for hlx 2004-5 df hlx 3004-5df and xten df. the spring arms that are still in use are now more than 10 years old. this new field action is launched to replace all remaining spring arms in combination with hlx 2004-5 df hlx 3004-5 df and xten df.

Device

SPRING ARM FOR 3004 TV
  • Model / Serial
    Model Catalog: ARD567910910 (Lot serial: up to SN 44060038859); Model Catalog: ARD567910901 (Lot serial: up to SN 35060032600); Model Catalog: ARD569002999 (Lot serial: up to SN 4306038616); Model Catalog: ARD567801093 (Lot serial: up to SN 36060033055); Model Catalog: ARD567801094 (Lot serial: up to SN 45060039322)
  • Product Description
    ARM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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