Events

Recall of DATEX-OHMEDA AS/3 ANESTHESIA DELIVERY UNIT SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GE HEALTHCARE FINLAND OY.

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
    37500
  • Event Risk Class
    II
  • Event Initiated Date
    2000-01-26
  • 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
    Datex-ohmeda has received reports stating reliability problems with the fresh gas delivery agent delivery and ventilation flinctions.

Device

DATEX-OHMEDA AS/3 ANESTHESIA DELIVERY UNIT SYSTEM
  • Model / Serial
    Model Catalog: A-FGC1 (Lot serial: S/N RANGE 40022203 AND ABOVE); Model Catalog: A-EV1 (Lot serial: S/N RANGE 40022203 AND ABOVE)
  • Product Description
    DATEX-OHMEDA AS/3 ANESTHESIA DELIVERY
  • Manufacturer
    GE HEALTHCARE FINLAND OY

Manufacturer

GE HEALTHCARE FINLAND OY
  • Manufacturer Address
    NEEDHAM
  • Source
    HC