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
    75051
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-19
  • 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
    When the gamma camera detector #1 head is at a position directly above the patient table (relative 180 degree position) oil and/or grease contamination on the radius drive clutch (es) may result in non-user initiated drifting down of the gamma camera detector #1 head towards the patient table. patient injury may result if a patient is on the table and the downward drift is not detected in time to execute emergency patient removal.

Device

VERTEX EPIC CAMERA/PEGASYS ULTRA IMAGING SYSTEM
  • Model / Serial
    Model Catalog: AMT-VERTEXE (Lot serial: >10 contact mfg); Model Catalog: AMT-VERTEXP (Lot serial: >10 contact mfg); Model Catalog: AMT-VERTEXA (Lot serial: >10 contact mfg)
  • Product Description
    Vertex Epic Camera / Pegasys Ultra Imaging System
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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