BEUDAMED
    FDA Recall Terminated

    Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)

    Recall: Z-0985-05 · Initiated June 27, 2005

    Recall

    Recall Number
    Z-0985-05
    Event Number
    32518
    Firm
    Natus Medical Inc
    FEI Number
    2938854
    Product Code
    ETY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2005
    Posted
    July 13, 2005
    Terminated
    January 9, 2006
    Address
    1501 Industrial Rd, San Carlos, CA, 94070

    Description

    Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)

    Reason

    Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

    Action

    The firm plans to provide corrections via removal/replacement of the affected units directly to end users in the U.S. and work with distributors to perform removal and correction abroad.

    Distribution

    Product was distributed worldwide, to distributors in Canada, Australia/New Zealand, Japan, the European Union, Bahamas, Bermuda, Chile, China, Hong Kong, INdia, Indonesia, Israel, Italy, Kuwait, Luxembourg, Malaysia, Nigeria, Quatar, Romania, Saudi Aabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan and Thailand.

    Quantity

    2473 units