Events

Recall of HELION S EXAM LIGHT (PART: ONDAL ACROBAT SWING 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
    26958
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-27
  • 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
    After an average seven years of use fatigue breaks at the plastic joint may occur. the likelihood of breaks increases with the frequency of moving the spring arm to its upper limit. a swing arm may rupture while in use or while in the inoperative position. if the joint breaks the swing arm falls down abruptly and without interruption. description of the product:helion s exam lights may be on mobile stands mounted from the ceiling or mounted from an equipment boom. typical locations for these lights are intensive care units and emergency departments exam rooms. swing arms were manufactured with either a white plastic joint or a metal joint. product with the metal joint is not affected by this recall.

Device

HELION S EXAM LIGHT (PART: ONDAL ACROBAT SWING SPRING ARM)
  • Model / Serial
    Model Catalog: H300 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    Helion S Exam Light (part: Ondal Acrobatr Swing Spring Arm)
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.