Events

Recall of VARIS TREATMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VARIAN MEDICAL SYSTEMS INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28368
  • Event Risk Class
    II
  • Event Initiated Date
    2008-07-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Software (sw) error in aria sw rt chart. aria radonc 8.1 needs to validate all mlc fields during the treatment approval of a plan. if validation fails no treatment is approved. error prevents this correction.

Device

VARIS TREATMENT
  • Model / Serial
    Model Catalog: PRODUCT CODE: HIT (Lot serial: HIT0437); Model Catalog: RELEASE 8.1 BUILD 8.1.18 (Lot serial: HIT0437); Model Catalog: SP1 & SP2 (Lot serial: HIT0437); Model Catalog: PRODUCT CODE: HIT (Lot serial: HIT1016); Model Catalog: RELEASE 8.1 BUILD 8.1.18 (Lot serial: HIT1016); Model Catalog: SP1 & SP2 (Lot serial: HIT1016); Model Catalog: PRODUCT CODE: HIT (Lot serial: HIT1432); Model Catalog: RELEASE 8.1 BUILD 8.1.18 (Lot serial: HIT1432); Model Catalog: SP1 & SP2 (Lot serial: HIT1432); Model Catalog: PRODUCT CODE: HIT (Lot serial: HIT1433); Model Catalog: RELEASE 8.1 BUILD 8.1.18 (Lot serial: HIT1433); Model Catalog: SP1 & SP2 (Lot serial: HIT1433); Model Catalog: PRODUCT CODE: HIT (Lot serial: HIT1481); Model Catalog: RELEASE 8.1 BUILD 8.1.18 (Lot serial: HIT1481); Model Catalog: SP1 & SP2 (Lot serial: HIT1481); Model Catalog: PRODUCT CODE: HIT (Lot serial: HIT1539); Model Catalog: SP1 & SP2 (Lot serial: HIT1539); Model Catalog: RELEASE 8.1 BUILD 8.1.18 (Lot serial: HIT1539)
  • Product Description
    Varian Medical Varis Treatment System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.