Events

Recall of ECLIPSE SMART SEGMENTATION

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
    84776
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-12
  • 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
    In affected eclipse versions user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. eclipse calculates dose for each field in a treatment plan and when all fields are calculated dose is summed and displayed to the user. if a treatment plan has been saved then reloaded from the database for additional planning activities user repositioning of mlc leaves may not invalidate or "clear" the calculated field dose. this condition is a result of how items are loaded into memory and subsequently handled for efficiency memory use when fields and mlc are saved and then recalled from database system defaults specify that objects may be unloaded from memory if 90% of available resources are consumed or as a periodic system maintenance task when the application is open for longer than 12 hours. in the rare instance that an mlc "object" is unloaded from memory due to one of these conditions the dose for that field will nolonger be conditional to the state of the mlc. in this case a change in the mlc leaf positions would not cause the field dose to be invalidated. this may go unnoticed if another field in the plan is not calculated and the total dose is not currently dislayed to the user.

Device

ECLIPSE SMART SEGMENTATION
  • Model / Serial
    Model Catalog: TPA001094000 (Lot serial: H484528); Model Catalog: TPA001094000 (Lot serial: H487407); Model Catalog: TPA001094000 (Lot serial: H487506); Model Catalog: TPA001094000 (Lot serial: H484527); Model Catalog: TPA001094000 (Lot serial: H484530); Model Catalog: UP9001 (Lot serial: >10 Serial Numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: H484531); Model Catalog: TPA001094000 (Lot serial: H484526); Model Catalog: 100042024 (Lot serial: >10 Serial numbers.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: >10 Serial numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.)
  • Product Description
    ECLIPSE SMART SEGMENTATION
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.