Events

Recall of Device Recall EZchange Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex - Ohmeda, Inc.

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
    38484
  • Event Risk Class
    Class 2
  • Event Number
    Z-0006-2008
  • Event Initiated Date
    2007-07-24
  • Event Date Posted
    2007-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53847
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    anesthesia system component - Product Code BSF
  • Reason
    Elevated inspired co2 levels related to the use of the datex-ohmeda ge healthcare disposable multi absorber canister with the ezchange module.
  • Action
    Because this issue only occurs when the Disposable Multi Absorber is used in conjunction with EZchange Module, they have contacted all EZchange Module customers. It is critical to contact these customers specifically, rather than all customers shipped Disposable Multi Absorbers as this may cause unwarranted confusion with customers who do not have the EZchange Module. Consignees were sent an letter dated 7/19/2007 describing the product and problem. The letter lists a number of interim actions to implement with the anesthesia systems.

Device

Device Recall EZchange Module
  • Model / Serial
    EZchange Manifold with part number 1407-7021-000,  1407-7027-000, M1053007, M1053008.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, Estonia, Finland, France, Germany, India, Ireland, Italy, Jordan, Republic of Korea, Kuwait, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Qatar, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • Manufacturer Address
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA