BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0006-2008 · Initiated July 24, 2007

    Recall

    Recall Number
    Z-0006-2008
    Event Number
    38484
    Firm
    Datex Ohmeda, Inc
    FEI Number
    2183066
    Product Code
    BSF
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    July 24, 2007
    Posted
    October 4, 2007
    Terminated
    October 16, 2015
    Address
    Po Box 7550, Madison, WI, 53707

    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.

    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.

    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.

    Quantity

    389,070