BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.

    Recall: Z-1428-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1428-2021
    Event ID
    87540
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 21, 2021
    Initiation Date
    February 26, 2021
    Classification Date
    April 15, 2021
    Termination Date
    December 15, 2023
    Address
    5900 Optical Ct, N/A, San Jose, CA, 95138-1400, United States

    Description

    Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.

    Reason

    Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

    Code Info

    PI20362910 PI20082806 PI20112868 PI20322887 PI20372920 PI16180922 PI20052735 PI20362908 PI20362911 PI20092807 PI20112869 PI20322888 PI20372921 PI17381211 PI20052740 PI20362909 PI20362913 PI20102835 PI20112870 PI20322889 PI20372922 PI17381214 PI20062759 PI20463033 PI20362912 PI20102836 PI20112871 PI20322890 PI20372923 PI18041369 PI20062766 PI20463038 PI20022723 PI20102839 PI20112872 PI20322891 PI20052734 PI18041410 PI20062768 PI20463041 PI20022724 PI20102846 PI20112873 PI20362892 PI20052736 PI18181490 PI20062771 PI20463042 PI20022725 PI20102851 PI20112874 PI20362893 PI20062747 PI18241579 PI20062772 PI20463046 PI20022726 PI20112852 PI20112875 PI20362894 PI20062754 PI19182075 PI20072773 PI20463049 PI20062749 PI20112860 PI20112876 PI20362895 PI20082802 PI19182080 PI20072780 PI20463051 PI20082795 PI20112861 PI20282879 PI20362896 PI20092808 PI19242192 PI20072781 PI20463052 PI20082797 PI20112862 PI20282880 PI20372914 PI20022701 PI19342372 PI20072784 PI20463054 PI20082798 PI20112863 PI20312881 PI20372915 PI20082788 PI19372413 PI20072787 PI20463058 PI20082799 PI20112864 PI20312882 PI20372916 PI20463062 PI19432511 PI20362904 PI20463036 PI20082801 PI20112865 PI20312883 PI20372917 PI14350291 PI20052727 PI20362905 PI20082804 PI20112866 PI20322885 PI20372918 PI15150533 PI20052728 PI20362906 PI20082805 PI20112867 PI20322886 PI20372919 PI15240575 PI20052732 PI20362907

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IL, MA MI, MS NC, NV, OK, PA, SC, TN, TX, VA, WA, WI and the countries of AE, CA, CN, CZ, DE, ES, HK, JP, KR, KW, MX, MY, PH, RO, SG, TR, TW.

    Quantity

    125 units