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FDAFDA · Food and drugs·Recall number Z-3160-2024

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system

Published September 25, 2024 · Recall initiated: July 23, 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

Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare
Distributor
Worldwide distribution.
Lot
UDI/DI: 00840682102988: a) 2110344-008, Installed Product ID Numbers: B54834-Centricity Universal Viewer Zero Footprint / ZFP-02394744, KMCH-Centricity Universal Viewer Zero Footprint / ZFP-01819848, 355920-Centricity Universal Viewer Zero Footprint / ZFP-20996307, 225717-Centricity Universal Viewer Zero Footprint / ZFP-19666806, RF0827-Centricity Universal Viewer Zero Footprint / ZFP-19460712; b) 2110344-009, Installed Product ID Numbers: 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372918, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348000, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348009, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348010, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348035, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-19632983, SA1008-Centricity Universal Viewer Zero Footprint / ZFP-20620864; c) 2110344-010, Installed Product ID Numbers: 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098227, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098228, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-14194760, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023936, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023938, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023939, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023940, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023941, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023942, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-17192653, 1472-19-Centricity Universal Viewer Zero Footprint / ZFP-22125883, 946739-Centricity Universal Viewer Zero Footprint / ZFP-14767595, 753891-Centricity Universal Viewer Zero Footprint / ZFP-21739897, 753891-Centricity Universal Viewer Zero Footprint / ZFP-19737302, JP-340499-Centricity Universal Viewer Zero Footprint / ZFP-01275434, RU8902-Centricity Universal Viewer Zero Footprint / ZFP-17775055, RU9383-Centricity Universal Viewer Zero Footprint / ZFP-16868184; d) 2110344-011, Installed Product ID Numbers: 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-01564901, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098755, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098757, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098758, 4084-1-Centricity Universal Viewer Zero Footprint / ZFP-02301039, 100085-5-Centricity Universal Viewer Zero Footprint / ZFP-20036722; e) 2110344-013, Installed Product ID Numbers: RU1473-Centricity Universal Viewer Zero Footprint / ZFP-02331227, RU3152-Centricity Universal Viewer Zero Footprint / ZFP-02314018, RF1194-Centricity Universal Viewer Zero Footprint / ZFP-19716329, RU6265-Centricity Universal Viewer Zero Footprint / ZFP-20080267, RU1107-Centricity Universal Viewer Zero Footprint / ZFP-01620728, RU9227-Centricity Universal Viewer Zero Footprint / ZFP-20080351, RU8412-Centricity Universal Viewer Zero Footprint / ZFP-19727241, RU7361-Centricity Universal Viewer Zero Footprint / ZFP-20084480; f) 2110344-019, Installed Product ID Numbers: 104586-2-Centricity Universal Viewer Zero Footprint / ZFP-01299076, 8121-6-Centricity Universal Viewer Zero Footprint / ZFP-01808438, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01367875, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372919, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372920, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372921, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372922, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-00556036, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-00556037, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347655, 444402-Centricity Universal Viewer Zero Footprint / ZFP-20091853, JP-340206-Centricity Universal Viewer Zero Footprint / ZFP-01275380, JP-690277-Centricity Unive
Risk classification
Class II
Area (FDA)
device
Country
United States

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