Events

Recall of PROTEUS XR/A GENERAL PURPOSE RADIOGRAPHIC SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    57242
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-10
  • 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
    If a device is improperly re-installed the collimator may not be properly seated and may loosen and fall. such an event may occur immediately following re-installation during a service maintenance activity but may also occur a few months after a service activity and continued use. a fall of a collimator while the system is in use could result in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.

Device

PROTEUS XR/A GENERAL PURPOSE RADIOGRAPHIC SYSTEM
  • Model / Serial
    Model Catalog: 2259988 (Lot serial: > 10 numbers contact mfg.); Model Catalog: GTC14064PC-2 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    PROTEUS XR/A GENERAL PURPOSE RADIOGRAPHIC SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)