Recall of BRIGHTVIEW GAMMA CAMERA SYSTEM WITH 3/8" CRYSTAL

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
    68044
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-17
  • Event Country
  • 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
    There is a gap between the stationary portion of the table and the extendable patient pallet. when the pallet is being translated patients' body parts (e.G. hair skin or fingers) or items (such as clothes and iv tubing) may get caught between the stationary portion of the table and extendable patient pallet if the instructions for use are not followed.

Device

  • Model / Serial
    Model Catalog: 2170-3000A (Lot serial: )
  • Product Description
    BRIGHTVIEW GAMMA CAMERA SYSTEM WITH 3/8" CRYSTAL
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
  • Source
    HC