FDAFDA · Food and drugs·Recall number 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
Published October 16, 2024 · Recall initiated: August 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare
- Distributor
- Worldwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.