Events

Safety Alert for Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Varian Medical Systems, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-03-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120319.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: varian optical guidance platform (ogp) with frameless array module hz1/hz6 it comes to our attention that an issue has been identified with the varian optical guidance platform (ogp), v 2.6 and 2.6.1 of a possible infrared light reflection resulting in an inability to calibrate the ogp or track the optical guidance tool (accessory) during use. as a result, the ogp may be unable to track the positioning tool or in one reported case, display an improper correction vector. the risk associated with this error is the offset at isocentre of the beam by 2 mm, which can result in severe injury, death or permanent total disability. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.