Events

Recall of DATEX-OHMEDA S/5 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
    14732
  • Event Risk Class
    II
  • Event Initiated Date
    2001-06-25
  • 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
    Under certain conditions the adu may deliver air instead of n2o as the air/n2o selector becomes stuck in the air position.

Device

DATEX-OHMEDA S/5 ANESTHESIA DELIVERY UNIT SYSTEM
  • Model / Serial
    Model Catalog: A-FGC1 (Lot serial: 40089399-40089401 40089403); Model Catalog: A-FGC1 (Lot serial: 40089382-40089384 40089386); Model Catalog: A-FGC1 (Lot serial: 40089371-40089373 40089377); Model Catalog: A-FGC1 (Lot serial: 40089331 40089341 40089370); Model Catalog: A-FGC1 (Lot serial: 40085680 40085682 40085733); Model Catalog: A-FGC1 (Lot serial: 40084527 40085652 40085679-); Model Catalog: A-FGC1 (Lot serial: 40084519 40084522 40084525-); Model Catalog: A-FGC1 (Lot serial: 40084506 40084510 40084516-); Model Catalog: A-FGC1 (Lot serial: 40089404-40089407 40091299); Model Catalog: A-FGC1 (Lot serial: 40091303 40092340.); Model Catalog: A-FGC1 (Lot serial: 40088575 40088581-40088584)
  • Product Description
    DATEX-OHMEDA S/5 ANESTHESIA DELIVERY UN
  • Manufacturer
    GE HEALTHCARE FINLAND OY

Manufacturer

GE HEALTHCARE FINLAND OY
  • Manufacturer Address
    NEEDHAM
  • Source
    HC