Events

Recall of ILED 5 SURGICAL LIGHT

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
    26973
  • Event Risk Class
    II
  • Event Initiated Date
    2016-01-25
  • 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
    Manufacturer has received information stating the iled and trulight lighting systems have fallen from the central axis. the reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. the investigation of this issue has determined the root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. the snap ring is located inside the interface and holds the spring arm in place. if the snap ring is installed improperly the spring arm of the lighting system can descend over time and eventually fall from the central axis. when the snap ring has been installed properly the potential for the lighting system to fall does not exist.

Device

ILED 5 SURGICAL LIGHT
  • Model / Serial
    Model Catalog: 1510-2 (Lot serial: All lots); Model Catalog: T300 (Lot serial: All Lots); Model Catalog: 337556 (Lot serial: All lots); Model Catalog: 1500 (Lot serial: All lots); Model Catalog: 1510 (Lot serial: All lots); Model Catalog: 337547 (Lot serial: All lots); Model Catalog: 337541 (Lot serial: All lots); Model Catalog: TE300H (Lot serial: All Lots); Model Catalog: TE551-2 (Lot serial: All Lots); Model Catalog: TE330 (Lot serial: All Lots); Model Catalog: 337542 (Lot serial: All lots); Model Catalog: 337618 (Lot serial: All lots); Model Catalog: 1331 (Lot serial: All lots); Model Catalog: 1430 (Lot serial: All lots); Model Catalog: 337540 (Lot serial: All lots); Model Catalog: 337550 (Lot serial: All lots); Model Catalog: 1340 (Lot serial: All lots); Model Catalog: 1310 (Lot serial: All lots); Model Catalog: 1300 (Lot serial: All lots); Model Catalog: 1330 (Lot serial: All lots); Model Catalog: 1320 (Lot serial: All lots); Model Catalog: T510-2 (Lot serial: All Lots); Model Catalog: T510 (Lot serial
  • Product Description
    ILED 5 SURGICAL LIGHT;TRULIGHT 5000 SURGICAL LIGHT;TRULIGHT 3000 SURGICAL LIGHT;ILED 3 SURGICAL LIGHT;TRUVIDIA
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.