Events

Recall of ON-BOARD IMAGER

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
    131793
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-30
  • 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
    An anomaly has been identified in the 3d match environment of obi 1.3 obi 1.4 obi 1.5 truebeam 1.0 and offline review 1.0 - 2.0 when using reference ct datasets which contain a critical number of slices. [note that the 3d match environments of truebeam 1.5 and offline review 2.1 are not affected by this anomaly.] when these reference ct datasets are used to create a reference ct volume in the 3d match environment in a small number of cases the scaling of the ct volume will be incorrect and the ct volume will appear larger - in the slice direction - than it actually should be. if this improperly scaled ct volume is used for 3d matching the cbct volume and patient may be positioned too far superiorly. because of differences in software design obi 1.5 is much more likely to exhibit this behavior than the other products identified.

Device

ON-BOARD IMAGER
  • Model / Serial
    Model Catalog: OBI (Lot serial: Contact manufacturer.); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: OBI (Lot serial: >10 serial numbers.); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069)
  • Product Description
    On Board Imager
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.