Events

Recall of SEQUENCER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC 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
    71852
  • Event Risk Class
    III
  • Event Initiated Date
    2010-02-26
  • 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
    The database conversion utility used during the varian 4d sites upgraded to 1.60w3 2.0t2 2.10l5 and 2.10m7 errantly changes the start gantry angle to zero thereby leading to mistreatment of targeted area resulting in no treatment or treating a non target area.

Device

SEQUENCER
  • Model / Serial
    Model Catalog: (Lot serial: MOSAIQ 2.10M7 (all packs)); Model Catalog: (Lot serial: MOSAIQ 2.10L5 (all packs)); Model Catalog: (Lot serial: MOSAIQ 2.00T2 (all packs)); Model Catalog: (Lot serial: MOSAIQ 1.60W (all packs))
  • Product Description
    Sequenser for MOSAIQ Upgrade
  • Manufacturer
    ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.

Manufacturer

ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.
  • Manufacturer Address
    SUNNYVALE
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC