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
    33120
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-08
  • 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
    Issue with mosaiq that could affect any treatment field defined with mlc leaves at the time of rtp import of treatment plans. a product defect truncates the mlc leaf values upon the import of a treatment plan after the 3d image viewer has been opened if the workstation on which the import was executed is configured to use a comma() as the decimal separator. this involves sequencer for mosaiq 2.20.08 (first build released may 2011) including all released builds and service packs of version and version 2.00x3sp6 (first build released sept 2011).

Device

SEQUENCER

Manufacturer

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