Recall of ARIA OFFLINE REVIEW SOFTWARE

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
    135800
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-10
  • Event Country
  • 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
    An anomaly exists in the software which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. if the change to the plan had been to parameters other than dose per fraction treatment to incorrect volume could resultpotentially leading to serious injury.

Device

  • Model / Serial
    Model Catalog: HIT (Lot serial: contact manufacturer.); Model Catalog: 8.6.07 (Lot serial: contact manufacturer.); Model Catalog: 8.5.11 (Lot serial: contact manufacturer.); Model Catalog: 8.1.15 (Lot serial: contact manufacturer.); Model Catalog: HIT (Lot serial: >10 serial numbers.); Model Catalog: 8.1.15 (Lot serial: >10 serial numbers.); Model Catalog: 8.6.07 (Lot serial: >10 serial numbers.); Model Catalog: 8.5.11 (Lot serial: >10 serial numbers.); Model Catalog: HIT (Lot serial: contact manufacturer); Model Catalog: 8.6.07 (Lot serial: contact manufacturer); Model Catalog: 8.5.11 (Lot serial: contact manufacturer); Model Catalog: 8.1.15 (Lot serial: contact manufacturer)
  • Product Description
    Aria Offline Review Software
  • Manufacturer

Manufacturer