Events

Recall of OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM

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
    19934
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-28
  • 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 with the optical guidance platform (ogp) software v2.6 and v2.6.1. this defect causes lat error of 0.8mm - 1mm for datasets arriving to optical guidance platform (ogp) from eclipse and other planning systems in the left side first orientation. this issue is only applicable to sites using direct eclipse or other non fastplan 3rd party treatment planning software that send data in true dicom format. this issue afects body array frameless array and frameless array srs.

Device

OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM
  • Model / Serial
    Model Catalog: 97525005A (Lot serial: HZ12066); Model Catalog: 97525005A (Lot serial: HZ17010); Model Catalog: 97525005A (Lot serial: HZ19078)
  • Product Description
    OPTICAL GUIDANCE PLATFORM - OPTICAL POSITIONING SYSTEM
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.