Events

Recall of ONDAL ACROBRAT 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
    66074
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-27
  • 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
    Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds in the front joint of spring arms over time when subject to extreme forces. trumpf medical does not have complaints related to this failure mode. the supplier has advised that a visual inspection of the welded joints should be completed on a bi-annual basis (every two years) as advised in the user manual since july 2010. this inspection should therefore be occurring for all trumpf medical surgical light camera and monitor arm system spring arms.

Device

ONDAL ACROBRAT SPRING ARM
  • Model / Serial
    Model Catalog: 1528403 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1513140 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1400191 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1441784 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1558932 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    ONDAL ACROBRAT SPRING ARM
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.