Events

Safety Alert for TomoTherapy Treatment Systems Hi‧Art versions 4.0.x, and HD versions 1.0.x

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by TomoTherapy Treatment 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
    2011-07-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110721.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: tomotherapy treatment systems hi‧art versions 4.0.X, and hd versions 1.0.X tomotherapy has issued a field safety notice to customers of tomotherapy treatment systems with hi·art versions 4.0.X, and hd versions 1.0.X. there is an anomaly in the software, in which during dicom export of plan level images with a non square exported field of view, an anomaly in the process of squaring the plan level image may cause the image to shift with respect to rois and dose. according to the local supplier, the affected products are available in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

TomoTherapy Treatment Systems Hi‧Art versions 4.0.x, and HD versions 1.0.x
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [20 Jul 2011] TomoTherapy Treatment Systems Hi‧Art versions 4.0.x, and HD versions 1.0.x
  • Manufacturer
    TomoTherapy Treatment Systems

Manufacturer

TomoTherapy Treatment Systems