BEUDAMED
    FDA Enforcement Class II Ongoing

    Artis pheno- Model No. 10849000

    Recall: Z-1646-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1646-2022
    Event ID
    90771
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    September 7, 2022
    Initiation Date
    August 10, 2022
    Classification Date
    August 26, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Artis pheno- Model No. 10849000

    Reason

    Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

    Code Info

    UDI-DI: 04056869046877 Serial Numbers 164766 164140 164138 164287 164740 164210 164183 164184 164776 164312 164071 164034 164391 164763 164306 164735 164277 164095 164072 164771 164743 164048 164741 164241 164186 164069 164213 164728 164263 164060 164113 164398 164366 164279 164774 164074 164084 164086 164098 164153 164330 164389 164394 164772 164718 164163 164297 164778 164333 164377 164397 164300 164105 164227 164022 164250 164739 164703 164187 164211 164100 164097 164775 164303 164352 164726 164724 164760 164371 ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan; Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.

    Quantity

    1,389 (590 US; 799 OUS) (Total)