Events

Safety Alert for OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0

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

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
    2011-11-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111117b.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 obi 1.3, obi 1.4; obi 1.5; truebeam 1.0; offline review 1.0 - 2.0 medical device manufacturer, varian, has issued an urgent medical device correction concerning obi 1.3, obi 1.4; obi 1.5; truebeam 1.0; offline review 1.0 - 2.0. an anomaly has been identified in the 3d match environment of obi 1.3, obi 1.4, obi 1.5, truebeam 1.0 and offline review 1.0 – 2.0 when using reference ct datasets which contain a critical number of slices. when these reference ct datasets are used to create a reference ct volume in the 3d match environment, in a small number of cases, the scaling of the ct volume will be incorrect and the ct volume will appear larger – in the slice direction - than it actually should be. if this improperly scaled ct volume is used for 3d matching, the cbct volume and patient may be positioned too far superiorly. according to the local supplier, the affected device has been distributed in hong kong. varian has notified all possibly affected customers and developing a correction for this issue. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
  • Manufacturer
    Varian

Manufacturer

Varian