Events

Recall of OEC MINIVIEW 6800 DIGITAL MOBILE C-ARM-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
    79272
  • Event Risk Class
    II
  • Event Initiated Date
    2008-07-23
  • 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
    The process history records (phrs) associated with a workstation pre-test contained varying degrees of copied information.

Device

OEC MINIVIEW 6800 DIGITAL MOBILE C-ARM-UNIT
  • Model / Serial
    Model Catalog: 00-870637-02 (Lot serial: CONTACT); Model Catalog: 00-870637-02 (Lot serial: MANUFACTURER); Model Catalog: 00-870637-02 (Lot serial: >10 NUMBERS); Model Catalog: 00-870632-05 (Lot serial: >10 NUMBERS); Model Catalog: 2274023 (Lot serial: >10 NUMBERS); Model Catalog: 00-870632-05 (Lot serial: CONTACT); Model Catalog: 2274023 (Lot serial: CONTACT); Model Catalog: 00-870632-05 (Lot serial: MANUFACTURER); Model Catalog: 2274023 (Lot serial: MANUFACTURER); Model Catalog: 2350023 (Lot serial: S/N'S 5613PU5 3499PU1); Model Catalog: 2350023 (Lot serial: 3575PU8 3584PU0 3574PU1); Model Catalog: 2350023 (Lot serial: 3537PU8 3496PU7 4803PU3); Model Catalog: 2350023 (Lot serial: 5246PU4); Model Catalog: 00-870638-02 (Lot serial: P4-0400-R); Model Catalog: 00-870638-02 (Lot serial: P6-0404-R P6-0396-L); Model Catalog: 00-870638-02 (Lot serial: P4-0433-R P4-0376-R); Model Catalog: 00-870638-02 (Lot serial: S/N'S P6-0528-R P6-0390-R)
  • Product Description
    OEC MINIVIEW 6800 DIGITAL MOBILE C-ARM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)