BEUDAMED
    FDA Recall Terminated

    Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236

    Recall: Z-0788-04 · Initiated February 19, 2004

    Recall

    Recall Number
    Z-0788-04
    Event Number
    28455
    Firm
    Spencer Technologies, Inc.
    FEI Number
    3003139439
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 19, 2004
    Posted
    July 20, 2004
    Terminated
    January 7, 2005
    Address
    701 16th Ave, Seattle, WA, 98122-4525

    Description

    Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236

    Reason

    Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.

    Action

    Beginning on 2/19/04 the firm sent a letter dated 2/17/04 to customers via US Mail. The letter describes the malfunctions, how to avoid the malfunction and advises the customer they will be receiving a software upgrade which will resolve the problem.

    Distribution

    Devices were distributed to 91 end users (hospitals, medical centers) and 2 distributors throughout the US. Foreign distribution included 3 distributors and 14 end users.

    Quantity

    147