BEUDAMED
    FDA Recall Terminated

    Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), L7901 series, and L8031 series (100kV type MICROFOCUS x-ray source

    Recall: Z-1224-2012 · Initiated March 30, 2011

    Recall

    Recall Number
    Z-1224-2012
    Event Number
    60991
    Firm
    Hamamatsu Corporation
    FEI Number
    1000121818
    Product Code
    RBS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 30, 2011
    Posted
    March 29, 2012
    Terminated
    January 29, 2018
    Address
    360 Foothill Rd, Bridgewater, NJ, 08807

    Description

    Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), L7901 series, and L8031 series (100kV type MICROFOCUS x-ray source

    Reason

    It was discovered that the Micro Focus X-ray Source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator.

    Action

    Hamamtsu Corporation sent a Warning letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CDRH approves your CAP under the following conditions: 1. Hamamatsu is able to work with your manufacturer customers to assure the revised manual and new label are provided to your customers' end users. 2. Hamamatsu informs CDRH if you receive information which indicates this control defect has occurred. Relevant information includes direct communication from customers or through observation of excessive wear on returned x-ray tubes. For questions regarding this recall call 908-231-0960, ext 2300.

    Distribution

    Worldwide Distribution-- USA (nationwide) and the country of Canada.

    Quantity

    100