Events

Recall of ONDAL ACROBAT 2000 SPRING ARM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    25143
  • Event Risk Class
    III
  • Event Initiated Date
    2010-11-05
  • 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
    Ondal acrobat 2000 spring arms manufactured between 2000 and 2006 and used in some helion and xenion surgical light systems may develop metal fatigue fractures over time on the front of the spring arm. arms holding non-camera ready light heads and flat panels are affected too.

Device

ONDAL ACROBAT 2000 SPRING ARM
  • Model / Serial
    Model Catalog: AC2000 (Lot serial: 0111 010 XXXXX-0111 066 XXXXX)
  • Product Description
    ONDAL ACROBAT 2000 SPRING ARM
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.