Events

Recall of INTEGRIS BH5000 CARDIOLOGY 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
    24116
  • Event Risk Class
    II
  • Event Initiated Date
    2009-05-12
  • 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
    A partial grid-switch failure may occur in allura xper and integris systems that may result in a higher x-ray dose than expected. this issue may pose a risk for patients or users. the potential failure can lead to a radiation exposure rate in excess of the 11.5 r/min health canada requirement. however it will only occur if the grid switch fails during fluoroscopy examinations using high kv values.

Device

INTEGRIS BH5000 CARDIOLOGY IMAGING SYSTEM
  • Model / Serial
    Model Catalog: 722021 (Lot serial: ); Model Catalog: (Lot serial: ); Model Catalog: 722042* (Lot serial: N/A); Model Catalog: ALLURA XPER FD10 (Lot serial: ); Model Catalog: 722016 (Lot serial: ); Model Catalog: 722017 (Lot serial: ); Model Catalog: 722041* (Lot serial: N/A); Model Catalog: 722044* (Lot serial: ); Model Catalog: 722043* (Lot serial: )
  • Product Description
    INTEGRIS BH5000 CARDIOLOGY IMAGING SYST
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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