Events

Recall of XTEN HLX 3004 HLX 3005

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
    55436
  • Event Risk Class
    III
  • Event Initiated Date
    2009-09-24
  • 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
    Excessive strain may cause impairment of the interlocking between the arm joint and surgical light. inapropriate handling may cause a crack on the front pivot of the acrobat 2000 spring arm.

Device

XTEN HLX 3004 HLX 3005
  • Model / Serial
    Model Catalog: ARD 567801093 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: ARD 567801094 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: ARD 567910901 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: ARD 567910910 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Product Description
    XTEN HLX 3004 HLX 3005
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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