Events

Recall of AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STERIS CANADA INCORPORATED.

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
    66198
  • Event Risk Class
    III
  • Event Initiated Date
    2010-03-01
  • 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
    Steris has learned that some customers may experience premature bulb failures due to loosening of wires and overheating of the lamp housing assemblies within the harmony la lc 500 and la 700 surgical lighting and media systems.

Device

AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
  • Model / Serial
    Model Catalog: HARMONY 500 AND 700 (Lot serial: S/N: B0428102135 - B0430207104)
  • Product Description
    AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC