Events

Recall of STERIS HARMONY LL 500/700 SURGICAL LIGHT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL SYSTEMS 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
    36016
  • Event Risk Class
    II
  • Event Initiated Date
    2004-01-13
  • 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
    An adjustment screw in the upper spring arm joint may break off due to material fatigue.

Device

STERIS HARMONY LL 500/700 SURGICAL LIGHT
  • Model / Serial
    Model Catalog: (Lot serial: FROM JULY 2002 TO JULY 2003)
  • Product Description
    STERIS HARMONY LL 500/700
  • Manufacturer
    DRAEGER MEDICAL SYSTEMS INC.

Manufacturer

DRAEGER MEDICAL SYSTEMS INC.
  • Manufacturer Address
    TELFORD
  • Source
    HC