BEUDAMED
    FDA Enforcement Class II Terminated

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    Recall: Z-2888-2016 · Reported October 5, 2016

    Enforcement

    Recall Number
    Z-2888-2016
    Event ID
    75160
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spiegelberg Gmbh & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2016
    Initiation Date
    December 29, 2009
    Classification Date
    September 26, 2016
    Termination Date
    October 5, 2016
    Address
    Tempowerkring 4, N/A, Hamburg, N/A, N/A, Germany

    Description

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    Reason

    In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.

    Code Info

    Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122

    Distribution

    Nationwide Distribution to PA only

    Quantity

    22 units