Events

Recall of ECLIPSE TPS V8.8

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
    51437
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-18
  • 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 eclipse the model for linear accelerator treatment head consists of both upper and lower jaws with an optional mlc. in the case of a treatment machine where the mlc replaces the lower moveable jaws (eg. siemens mlc and ge mlc) the lower jaw and mlc is represented in eclipse by combination of virtual jaws and an mlc. the calculation will treat the virtual jaw as a beam limiting device such that the resultant dose distribution will be bounded by the virtual jaw if it lies within the mlc aperture. when calculating or approving a treatment plan if a virtual jaw is positioned inside the mlc aperture a warning will be displayed in external beam planning task when planning for siemens mlc accelerator. this warning states that the virtual collimator jaws are positioned inside the mlc aperture a position which is not physically possible. this warning message is not displayed in case of other accelerator types without back up jaws (eg. ge saturne with ge mlc) or when irreg planning task is being used. if the user proceeds with the calculation the virtual jaws will remain in the current position and will be handled as a beam limiting device for the dose calculation. this will result in the region under the virtual jaw but within the mlc aperture showing no or low dose. treatment using such a plan will result in dose being delivered to the patient outside of the area indicated in the planned dose distribution and within the entire mlc aperture.

Device

ECLIPSE TPS V8.8
  • Model / Serial
    Model Catalog: 100042024 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: TPA001075000 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: TPA001075000 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: 100042024 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: UP9001 (Lot serial: H481364); Model Catalog: UP9001 (Lot serial: H482173)
  • Product Description
    Eclipse Treatment Planning System V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.