Events

Recall of RPM RESPIRATORY GATING 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
    145646
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-28
  • 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
    Varian has identified an anomaly with the rpm respiratory gating system version 1.7.5 with 3d option. while operating with the 6-dot marker block this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.

Device

RPM RESPIRATORY GATING SYSTEM
  • Model / Serial
    Model Catalog: 100012503-01 (Lot serial: >10 numbers contact mfg)
  • Product Description
    RPM Respiratory Gating System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.