Events

Recall of HARMONY VLED SURGICAL LIGHTING 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
    78728
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-15
  • 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
    Groups of steris harmanoy vled surgical lights (modules) contained within the vled light head may illuminate inconsistently. this issue is observed when the user attempts to adjust the lighting's display intensity via the lighting system's wall-mounted user interface panel.

Device

HARMONY VLED SURGICAL LIGHTING SYSTEM
  • Model / Serial
    Model Catalog: B136824175 (Lot serial: 0426614048); Model Catalog: B136824176 (Lot serial: 0426614048); Model Catalog: B136824176 (Lot serial: 0430714094); Model Catalog: B136824175 (Lot serial: 0430714095); Model Catalog: B136824176 (Lot serial: 0430714095); Model Catalog: B136824175 (Lot serial: 0430714094)
  • Product Description
    Harmony vLed Surgical Lighting System
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

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