BEUDAMED
    FDA Recall Terminated

    Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.

    Recall: Z-2581-2011 · Initiated April 26, 2011

    Recall

    Recall Number
    Z-2581-2011
    Event Number
    58854
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    DXQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 26, 2011
    Posted
    June 22, 2011
    Terminated
    May 28, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.

    Reason

    BP cuffs may not properly inflate due to a leak

    Action

    GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 26, 2011 to all affected customers. The letter identified the product, the problem and the action to be taken. Customers were instructed to discontinue use of the product, isolate all affected products, return only unused products and distribute this letter to any other healthcare institutions that are potentially affected by this issue. The letter asks that each customer complete and return the enclosed confirmation form via fax to 800-535-7923, in order to confirm receipt of the notification letter. For any questions, contact your local Vital Signs Account Manager or the International Customer Service at 1-800-932-0760.

    Distribution

    Worldwide Distribution -- USA (nationwide) including Puerto Rico and countries of: Argentina, Australia, Belgium, Canada, Chile, Ecuador, Finland, Germany, Hong Kong, Israel, Italy, Latvia, Lebanon, Nicaragua, Panama, Peru, Saudi Arabia, Slovenia, UK, Uruguay and Venezuela

    Quantity

    2,684,996 units