Events

Recall of OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT

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
    27252
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-10
  • 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
    There is a potential for the system to have a technique accuracy issue which is greater than the 10% specified per the product documentation. if the user rapidly increases or decreases the mas or kv on the display the technique displayed may be one renard step off or one kv increment off from what the actual exposure delivered will be. this will only occur if the technique is adjusted more than three selections. if the user adjusts the techniques again after this rapid selection prior to exposure the display of the techniques and the actual delivered technique will be the same. these situations are not compliant with iec 60601-2-54 clause 203.6.4.3.104.6.

Device

OPTIMA XR200AMX X-RAY SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 5555000-4 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-3 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 5555000-6 (Lot serial: 00001027061WK9); Model Catalog: 5555000-5 (Lot serial: 00001027300WK1); Model Catalog: 5555000-5 (Lot serial: 00001027061WK9); Model Catalog: 5555000-6 (Lot serial: 00001028024WK6); Model Catalog: 5555000-5 (Lot serial: 00001028024WK6); Model Catalog: 5555000-6 (Lot serial: 00001027195WK5); Model Catalog: 5555000-5 (Lot serial: 00001027195WK5); Model Catalog: 5555000-6 (Lot serial: 00001027893WK5); Model Catalog: 5555000-5 (Lot serial: 00001027893WK5); Model Catalog: 5555000-6 (Lot serial: 00001027826WK5); Model Catalog: 5555000-5 (Lot serial: 00001027826WK5); Model Catalog: 5555000-6 (Lot serial: 00001027346WK4); Model Catalog: 5555000-5 (Lot serial: 00001027346WK4); Model Catalog: 5555000-6 (Lot serial: 00001027263WK1); Model Catalog: 5555000-5 (Lot serial: 00001027263WK1); Model Catalog: 5555000-6 (Lot serial: 00001027300WK1); Model
  • Product Description
    OPTIMA XR200AMX X-RAY SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)