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FDA (Device enforcement)Recalled 2024-08-29class ii

GE Healthcare: 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)¿¿¿¿ 208

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 1500 units Lot/code info: 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-Centr

UPC codes

840682102988, 082455140084

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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