Events

Safety Alert for FrameArray Module HZ7 and Floorstand HZ5

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

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
    2011-10-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111007.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
    Urgent field safety notice: varian framearray module hz7 and floorstand hz5 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning head ring posts used by both the framearray module (of the optical guidance platform) hz7 and floorstand hz5, where the head ring posts may be damaged due to excessive mechanical stress, resulting in possible failure during usage. this could result in the movement of the headring relative to the patient’s anatomy. according to the supplier, the affected devices have been distributed in hong kong. varian is sending a notification letter to affected users to remind them to inspect their head ring posts and verify that they are using the current design and that it is labeled with the part number 970.284. if the posts are not labeled 970.284, customers should discontinue use and contact varian service for replacement. varian will also arrange an inspection of all head ring posts and replace affected units.

Device

FrameArray Module HZ7 and Floorstand HZ5
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian FrameArray Module HZ7 and Floorstand HZ5
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems