Events

Recall of VISUM LED SURGICAL LIGHT

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

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
    53313
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-07
  • 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
    Stryker has become aware that there is a remote likelihood that the eds light suspension central axis may have an insufficiently assembled joint in the suspension. the eds systems have redundant connections throughout the suspensions. if the eds light suspension central axis falls it could potentially cause serious injuries to healthcare providers and/or patients. to date there have been no adverse events reported for this issue.

Device

VISUM LED SURGICAL LIGHT
  • Model / Serial
    Model Catalog: 0682-001-435 (Lot serial: 0682-001-286); Model Catalog: 0682-001-434 (Lot serial: 0682-001-286); Model Catalog: 0682-001-433 (Lot serial: 0682-001-286); Model Catalog: 0682-001-300 (Lot serial: 0682-001-286); Model Catalog: 0682-001-229 (Lot serial: 0682-001-286); Model Catalog: 0682-001-298 (Lot serial: 0682-001-286); Model Catalog: 0682-001-286 (Lot serial: 0682-001-286); Model Catalog: 0682-001-432 (Lot serial: 0682-001-286); Model Catalog: 0682-001-435 (Lot serial: 0682-001-432); Model Catalog: 0682-001-434 (Lot serial: 0682-001-432); Model Catalog: 0682-001-433 (Lot serial: 0682-001-432); Model Catalog: 0682-001-300 (Lot serial: 0682-001-432); Model Catalog: 0682-001-229 (Lot serial: 0682-001-432); Model Catalog: 0682-001-298 (Lot serial: 0682-001-432); Model Catalog: 0682-001-286 (Lot serial: 0682-001-432); Model Catalog: 0682-001-432 (Lot serial: 0682-001-432); Model Catalog: 0682-001-435 (Lot serial: 0682-001-435); Model Catalog: 0682-001-434 (Lot serial: 0682-001-435); Model Catalog:
  • Product Description
    EDS LIGHT SUSPENSION CENTRAL AXIS FOR VISUM LED SURGICAL LIGHT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC