Events

Recall of OEC FLEXIVIEW 8800 STANDARD C-ARM

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
    27177
  • Event Risk Class
    II
  • Event Initiated Date
    2006-08-03
  • 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
    While the system is saving data to the disk drive a sudden loss of power can cause patient data stored on the system to become corrupted which could result in lost x-ray images.

Device

OEC FLEXIVIEW 8800 STANDARD C-ARM
  • Model / Serial
    Model Catalog: (Lot serial: CONTACT MANUFACTURER); Model Catalog: (Lot serial: >100 NUMBERS); Model Catalog: (Lot serial: >10 NUMBERS); Model Catalog: (Lot serial: 86-0224 86-0066); Model Catalog: (Lot serial: S/Ns 86-0194 86-0266); Model Catalog: (Lot serial: P4-0060-R 86-0182 86-0018); Model Catalog: (Lot serial: 86-0018 86-0280 86-0293)
  • Product Description
    OEC FLEXIVIEW 8800 MOBILE IMAGING SYS.
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)