BEUDAMED
    FDA Recall 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 · Initiated December 29, 2009

    Recall

    Recall Number
    Z-2888-2016
    Event Number
    75160
    Firm
    Spiegelberg Gmbh & Co. KG Tempowerkring 4 Hamburg Germany
    FEI Number
    3002108226
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 29, 2009
    Terminated
    October 5, 2016

    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.

    Action

    Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products. Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them.

    Distribution

    Nationwide Distribution to PA only

    Quantity

    22 units