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
    71454
  • 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
    The initial date assigned to the plan is the date of the data transfer. this date is updated when any 'new' file is written into the directory. this date may change when performing other functions with a transferred patient file such as saving pre- recorded positions fiducial registration and report or patient settings. therefore exam transferred at time 't' but opened for a quick review in 't'+t may have the later timestamp leading to confusion at the time of exam selection. the risk is a user opens a previous exam for review and then 'saves' the file. they then go to open today's exam however they select the most recent exam (the one they just opened reviewed and saved) thinking it is treatment plan for the day when it is not.

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.