Events

Recall of VERTEX EPIC CAMERA/PEGASYS ULTRA IMAGING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    72542
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-16
  • 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
    Philips healthcare received a report from the field that during a manual collimator exchange procedure the operator was attempting to slide the collimator cassette containing the detector 2 vertex high resolution (vxhr) collimator from the collimator storage cabinet onto the collimator exchange carriage. as the vxhr collimator and collimator cassette was being slid onto the carriage the cassette did not align with the carriage top guide rollers and mechanical lock. the collimator and collimator cassette fell off of the carriage and onto the floor.

Device

VERTEX EPIC CAMERA/PEGASYS ULTRA IMAGING SYSTEM
  • Model / Serial
    Model Catalog: AMT-VERTEXE-ULTRA (Lot serial: ALL); Model Catalog: AMT-VERTEXA (Lot serial: ALL); Model Catalog: AMT-VERTEXP (Lot serial: ALL)
  • Product Description
    VERTEX EPIC CAMERA/PEGASUS ULTRA IMAGING SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC