FDAFDA · Alimentos y medicamentos·N.º oficial Z-0039-2025
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided
Publicado el 16 de octubre de 2024 · Inicio del retiro: 29 de agosto de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare
- Distribuidor
- Worldwide distribution.
- Lote
- a)¿¿¿¿¿2089507-120, UDI/DI 840682102988, Installed Product ID Numbers: JP-570093-Centricity Universal Viewer Zero Footprint / ZFP-02368762; b)¿¿¿¿ 2089507-129, UDI/DI 840682102988, Installed Product ID Numbers: 332068-Centricity Universal Viewer Zero Footprint / ZFP-19605736, 332068-Centricity Universal Viewer Zero Footprint / ZFP-20274641, RU9594-Centricity Universal Viewer Zero Footprint / ZFP-19628991; c)¿¿¿¿¿ 2089507-131, UDI/DI 840682102988, Installed Product ID Numbers: 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348317, 2722622-Centricity Universal Viewer Zero Footprint / ZFP-19663680, RU3232-Centricity Universal Viewer Zero Footprint / ZFP-20080525, RU1857-Centricity Universal Viewer Zero Footprint / ZFP-20022263; d)¿¿¿¿ 2089507-135, UDI/DI 840682102988, Installed Product ID Numbers: 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555361, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555362, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555363, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555364, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555365, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555367, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21286328, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21286332, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21767150, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21770700, 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21770743, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-19720328, 14398615-Centricity Universal Viewer Zero Footprint / ZFP-21286099, 082455140084-Centricity Universal Viewer Zero Footprint / ZFP-20697867, RU7950-Centricity Universal Viewer Zero Footprint / ZFP-02331578, RF2557-Centricity Universal Viewer Zero Footprint / ZFP-21209143, RU2636-Centricity Universal Viewer Zero Footprint / ZFP-20656772, RU1377-Centricity Universal Viewer Zero Footprint / ZFP-20613807, -Centricity Universal Viewer Zero Footprint / ZFP-02331243, RU1140-Centricity Universal Viewer Zero Footprint / ZFP-20278602, GPX234-Centricity Universal Viewer Zero Footprint / ZFP-24305099, GEE340-Centricity Universal Viewer Zero Footprint / ZFP-20641898, 81193-Centricity Universal Viewer Zero Footprint / ZFP-20274992; e)¿¿¿¿ 2089507-136, UDI/DI 840682102988, Installed Product ID Numbers: 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286833, 4325-52-Centricity Universal Viewer Zero Footprint / ZFP-02345640, 2812599-Centricity Universal Viewer Zero Footprint / ZFP-20502391, 2812599-Centricity Universal Viewer Zero Footprint / ZFP-20502392, 2812599-Centricity Universal Viewer Zero Footprint / ZFP-20502393; f)¿¿¿¿¿¿ 2089507-140, UDI/DI 840682102988, Installed Product ID Numbers: 010120-Centricity Universal Viewer Zero Footprint / ZFP-00044252, 010120-Centricity Universal Viewer Zero Footprint / ZFP-00044253, 010120-Centricity Universal Viewer Zero Footprint / ZFP-00044254, JP-070098-Centricity Universal Viewer Zero Footprint / ZFP-20081084, JP-340137-Centricity Universal Viewer Zero Footprint / ZFP-20483713, JP-360037-Centricity Universal Viewer Zero Footprint / ZFP-19669327, JP-360037-Centricity Universal Viewer Zero Footprint / ZFP-19669329, 332068-Centricity Universal Viewer Zero Footprint / ZFP-20274654, 1363272-Centricity Universal Viewer Zero Footprint / ZFP-01286173; g)¿¿¿¿¿ 2089507-144, UDI/DI 840682102988, Installed Product ID Numbers: 1499-1-Centricity Universal Viewer Zero Footprint / ZFP-20495561, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21286303, 656341-Centricity Universal Viewer Zero Footprint / ZFP-20548333, 283046-Centricity Universal Viewer Zero Footprint / ZFP-20542523, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20585448, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20679068, 283043-Centricity Universal Viewer Zero Footprint / ZFP-20679070, 283046-Cent
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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