Events

Recall of OPTICAL GUIDANCE PLATFORM - FRAMELESSARRAY SRS MODULE

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
    14545
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-26
  • 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
    Forceful insertion or extensive use of srs conical collimator mount may lead to damage of the conical collimator mount and clinac interface mount. the damage may cause the srs conical collimator mount to be displaced from its calibrated position. additionally the optical reader may be damaged.

Device

OPTICAL GUIDANCE PLATFORM - FRAMELESSARRAY SRS MODULE
  • Model / Serial
    Model Catalog: 97530302A (Lot serial: HZ17010)
  • Product Description
    Optical Guidance Platform - Framelessarray SRS Module
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.