BEUDAMED
    FDA Recall Terminated

    Datex-Ohmeda S/5 Aespire Anesthesia System 7100

    Recall: Z-0037-06 · Initiated September 27, 2005

    Recall

    Recall Number
    Z-0037-06
    Event Number
    33678
    Firm
    Datex-Ohmeda Inc
    FEI Number
    2183066
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2005
    Posted
    October 12, 2005
    Terminated
    April 1, 2007
    Address
    3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, WI, 53718

    Description

    Datex-Ohmeda S/5 Aespire Anesthesia System 7100

    Reason

    Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.

    Action

    Urgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.

    Distribution

    CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Republic, Ecuador, Finland, France, Germany, Ghana, Great Britain, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Oman, Palestine, Peru, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Arab Emerites, Venezuela & Vietnam.

    Quantity

    367