Events

Recall Or Safety Alert for All TomoTherapy Hi-ART Treatment Systems – operating on Version 4.0.0, 4.0.1 and 4.0.2 software

According to Ministry of Health Malaysia, this recall or safety alert involved a device in Malaysia that was produced by TomoTherapy Incorporated.

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
    Recall / Safety alert
  • Event Country
    Malaysia
  • Event Source
    MHM
  • Event Source URL
    https://portal.mda.gov.my/
  • Notes / Alerts
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Extra notes in the data
    ALERT: All TomoTherapy Hi-ART Treatment Systems – operating on Version 4.0.0, 4.0.1 and 4.0.2 software1. Letter from MDB 2. TomoTherapy Notice 1 3. TomoTherapy Notice 2 4. TomoTherapy Notice 3 5. TomoTherapy Notice 4

Device

All TomoTherapy Hi-ART Treatment Systems – operating on Version 4.0.0, 4.0.1 and 4.0.2 software

Manufacturer

TomoTherapy Incorporated