FDA Enforcement Class II Ongoing

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

Recall: Z-1475-2026 · Reported March 11, 2026

Enforcement

Recall Number
Z-1475-2026
Event ID
98368
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
GE Healthcare
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 11, 2026
Initiation Date
January 16, 2026
Classification Date
February 27, 2026
Address
500 W Monroe St, N/A, Chicago, IL, 60661-3671, United States

Description

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

Reason

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

Code Info

1) 2110344-039, UDI/DI 00840682102988, System ID Numbers: 105906-2-Centricity Universal Viewer Zero Footprint / ZFP-02312614, 4491-1-Centricity Universal Viewer Zero Footprint / ZFP-22180897, 10908-1-Centricity Universal Viewer Zero Footprint / ZFP-25199248, 10908-7-Centricity Universal Viewer Zero Footprint / ZFP-22203146, 10908-7-Centricity Universal Viewer Zero Footprint / ZFP-25188736, 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106869, 4263-3-Centricity Universal Viewer Zero Footprint / ZFP-00106870, 4263-5-Centricity Universal Viewer Zero Footprint / ZFP-01300798, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25222931, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248683, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248688, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248690, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248695, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248713, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-25248716, 3064-15-Centricity Universal Viewer Zero Footprint / ZFP-26608643, 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26580437, 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26694204, 10458-9-Centricity Universal Viewer Zero Footprint / ZFP-26694229, 105197-2-Centricity Universal Viewer Zero Footprint / ZFP-20813950, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-25210052, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-25210057, 4642-6-Centricity Universal Viewer Zero Footprint / ZFP-25210107, 103829-6-Centricity Universal Viewer Zero Footprint / ZFP-20900298, 103829-6-Centricity Universal Viewer Zero Footprint / ZFP-21180523, 103829-6-Centricity Universal Viewer Zero Footprint / ZFP-21180525, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-26390526, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-26694221, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-26694222, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-24463042, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-25239139, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-25239140, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-26714200, 10360-3-Centricity Universal Viewer Zero Footprint / ZFP-26714202, 3471-36-Centricity Universal Viewer Zero Footprint / ZFP-24399434, 3471-36-Centricity Universal Viewer Zero Footprint / ZFP-26295812, 1198-18-Centricity Universal Viewer Zero Footprint / ZFP-02348419, 1198-18-Centricity Universal Viewer Zero Footprint / ZFP-18990433, 1198-78-Centricity Universal Viewer Zero Footprint / ZFP-22223452, 100581-1-Centricity Universal Viewer Zero Footprint / ZFP-25168130, 8746-1-Centricity Universal Viewer Zero Footprint / ZFP-23900206, 8746-1-Centricity Universal Viewer Zero Footprint / ZFP-21318104, 1207-14-Centricity Universal Viewer Zero Footprint / ZFP-24836084, 2123-19-Centricity Universal Viewer Zero Footprint / ZFP-24836053, 102901-1-Centricity Universal Viewer Zero Footprint / ZFP-23251238, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466083, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-26132903, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-26132895, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466076, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466077, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466078, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466079, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-24466088, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098228, 103696-33-Centricity Universal Viewer Zero Footprint / ZFP-20098431, 103696-4-Centricity Universal Viewer Zero Footprint / ZFP-20036715, 4578-1-Centricity Universal Viewer Zero Footprint / ZFP-25014571, 100468-1-Centricity Universal Viewer Zero Footprint / ZFP-24480189, 2440-1-Centricity Universal Viewer Zero Footprint / ZFP-22206970, 613493-Centricity Universal Viewer Zero Footprint / ZFP-26356112, 672721-Centricity Universal Viewer Zero Footprint / ZFP-25151288, 313741-Centricity Universal Viewer Zero Footprint / ZFP-26548614, 101223-6-Centricity Universal Viewer Zero Footprint / ZFP-20569855, 101223-22-Centricity Universal Viewer Zero Footprint / ZFP-20575531, 101223-22-Centricity Universal Viewer Zero Footprint / ZFP-20575532, 101223-22-Centricity Universal Viewer Zero Footprint / ZFP-20575543, 101223-16-Centricity Universal Viewer Zero Footprint / ZFP-20575533, 101223-16-Centricity Universal Viewer Zero Footprint / ZFP-20575535, 283039-Centricity Universal Viewer Zero Footprint / ZFP-02283242, 283039-Centricity Universal Viewer Zero Footprint / ZFP-02170574, 283039-Centricity Universal Viewer Zero Footprint / ZFP-01819807, 104894-1-Centricity Universal Viewer Zero Footprint / ZFP-01225123, 104894-1-Centricity Universal Viewer Zero Footprint / ZFP-01225124, 659003-Centricity Universal Viewer Zero Footprint / ZFP-21180575, 659003-Centricity Universal Viewer Zero Footprint / ZFP-21200874, 659003-Centricity Universal Viewer Zero Footprint / ZFP-01265320, 659003-Centricity Universal Viewer Zero Footprint / ZFP-01265321, 659003-Centricity Universal Viewer Zero Footprint / ZFP-01265322, 659003-Centricity Universal Viewer Zero Footprint / ZFP-21200873, 659003-Centricity Universal Viewer Zero Footprint / ZFP-01265323, 659003-Centricity Universal Viewer Zero Footprint / ZFP-01225125, 659003-Centricity Universal Viewer Zero Footprint / ZFP-01265343, 659003-Centricity Universal Viewer Zero Footprint / ZFP-21207211, 1539601-Centricity Universal Viewer Zero Footprint / ZFP-26379461, A41676-Centricity Universal Viewer Zero Footprint / ZFP-21214076, 246573-Centricity Universal Viewer Zero Footprint / ZFP-26617853, M40455-Centricity Universal Viewer Zero Footprint / ZFP-00044391, C41917-Centricity Universal Viewer Zero Footprint / ZFP-00117236, D41917-Centricity Universal Viewer Zero Footprint / ZFP-00117239, M42001-Centricity Universal Viewer Zero Footprint / ZFP-02394845, 16921400-Centricity Universal Viewer Zero Footprint / ZFP-25194303, 509982-Centricity Universal Viewer Zero Footprint / ZFP-26608620, 509982-Centricity Universal Viewer Zero Footprint / ZFP-19670323, HC0220-Centricity Universal Viewer Zero Footprint / ZFP-01286629, HC0220-Centricity Universal Viewer Zero Footprint / ZFP-26660354, HC2720-Centricity Universal Viewer Zero Footprint / ZFP-00163499, UC2847-Centricity Universal Viewer Zero Footprint / ZFP-00260806, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-01461578, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-26703904, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-26703931, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-26703990, 600791-Centricity Universal Viewer Zero Footprint / ZFP-24944069, 600791-Centricity Universal Viewer Zero Footprint / ZFP-26859675, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-24467504, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-02286748, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624821, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624822, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624823, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624824, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624826, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624828, UC1989-Centricity Universal Viewer Zero Footprint / ZFP-26624829, 351738-Centricity Universal Viewer Zero Footprint / ZFP-26304641, 434487-Centricity Universal Viewer Zero Footprint / ZFP-22169581, 722453-Centricity Universal Viewer Zero Footprint / ZFP-25287444, 560496-Centricity Universal Viewer Zero Footprint / ZFP-26748573, HCNE01-Centricity Universal Viewer Zero Footprint / ZFP-20108177, 1257845X - 434487-Centricity Universal Viewer Zero Footprint / ZFP-22203508, 2010846X - 601860-Centricity Universal Viewer Zero Footprint / ZFP-24336091, HC0565-Centricity Universal Viewer Zero Footprint / ZFP-26608610, 4625913X - HC0565-Centricity Universal Viewer Zero Footprint / ZFP-25017402, X9001282-Centricity Universal Viewer Zero Footprint / ZFP-00001140, X9001282-Centricity Universal Viewer Zero Footprint / ZFP-26666351, X9001282-Centricity Universal Viewer Zero Footprint / ZFP-26666352, X9001282-Centricity Universal Viewer Zero Footprint / ZFP-26666354, X9001282-Centricity Universal Viewer Zero Footprint / ZFP-26666356, 4790503-Centricity Universal Viewer Zero Footprint / ZFP-26599556, 12711614-Centricity Universal Viewer Zero Footprint / ZFP-26449902, 81077-Centricity Universal Viewer Zero Footprint / ZFP-25304950, 81077-Centricity Universal Viewer Zero Footprint / ZFP-25329396, 591292-Centricity Universal Viewer Zero Footprint / ZFP-21198479, B53686-Centricity Universal Viewer Zero Footprint / ZFP-01271448, D58105-Centricity Universal Viewer Zero Footprint / ZFP-25204625, 16872968-Centricity Universal Viewer Zero Footprint / ZFP-24855625, 16872968-Centricity Universal Viewer Zero Footprint / ZFP-26929832, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-24448019, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-26640843, 16999320-Centricity Universal Viewer Zero Footprint / ZFP-24833747, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-24434112, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-24439350, 553884-Centricity Universal Viewer Zero Footprint / ZFP-25203487, 553884-Centricity Universal Viewer Zero Footprint / ZFP-26906289, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-24838806, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-24305476, 11388609-Centricity Universal Viewer Zero Footprint / ZFP-26127359, JP-283699-Centricity Universal Viewer Zero Footprint / ZFP-20978978, JP-260056-Centricity Universal Viewer Zero Footprint / ZFP-20587825, JP-330087-Centricity Universal Viewer Zero Footprint / ZFP-24931880, 851228-Centricity Universal Viewer Zero Footprint / ZFP-26136995, KW1018-Centricity Universal Viewer Zero Footprint / ZFP-26917029, KW1018-Centricity Universal Viewer Zero Footprint / ZFP-26917028, 60020-Centricity Universal Viewer Zero Footprint / ZFP-01819295, 17026623-Centricity Universal Viewer Zero Footprint / ZFP-25248193, 4510134-Centricity Universal Viewer Zero Footprint / ZFP-24525506, 17191257-Centricity Universal Viewer Zero Footprint / ZFP-26628542, 17066964-Centricity Universal Viewer Zero Footprint / ZFP-24484202, 1886799-Centricity Universal Viewer Zero Footprint / ZFP-25169256, 16951628-Centricity Universal Viewer Zero Footprint / ZFP-26453548, SA1232-Centricity Universal Viewer Zero Footprint / ZFP-25227096, SA1233-Centricity Universal Viewer Zero Footprint / ZFP-00066573, SA1013-Centricity Universal Viewer Zero Footprint / ZFP-22879437, SA1013-Centricity Universal Viewer Zero Footprint / ZFP-24281567, 17111683-Centricity Universal Viewer Zero Footprint / ZFP-21733830, 82667-Centricity Universal Viewer Zero Footprint / ZFP-25194300, 17021465-Centricity Universal Viewer Zero Footprint / ZFP-24487930, 747887-Centricity Universal Viewer Zero Footprint / ZFP-25210479, MPX431-Centricity Universal Viewer Zero Footprint / ZFP-24465830, MEX255-Centricity Universal Viewer Zero Footprint / ZFP-26802528, GED649-Centricity Universal Viewer Zero Footprint / ZFP-19666476, 947379-Centricity Universal Viewer Zero Footprint / ZFP-24846063, O051CA01-Centricity Universal Viewer Zero Footprint / ZFP-20618153, 228493-Centricity Universal Viewer Zero Footprint / ZFP-24821472, 407237-Centricity Universal Viewer Zero Footprint / ZFP-20997395, 730140-Centricity Universal Viewer Zero Footprint / ZFP-00038193, 0853550198-Centricity Universal Viewer Zero Footprint / ZFP-02093675, 6051-Centricity Universal Viewer Zero Footprint / ZFP-00116181, 6002-Centricity Universal Viewer Zero Footprint / ZFP-00158571, 486961-Centricity Universal Viewer Zero Footprint / ZFP-25022095, AE1564-Centricity Universal Viewer Zero Footprint / ZFP-00555894, AE1564-Centricity Universal Viewer Zero Footprint / ZFP-26560468, RWEAE-Centricity Universal Viewer Zero Footprint / ZFP-00165095, 243119-Centricity Universal Viewer Zero Footprint / ZFP-21322536, 243119-Centricity Universal Viewer Zero Footprint / ZFP-26631095, 370259-Centricity Universal Viewer Zero Footprint / ZFP-25309376, 370259-Centricity Universal Viewer Zero Footprint / ZFP-26784611, 17053632-Centricity Universal Viewer Zero Footprint / ZFP-24829942, 6345592-Centricity Universal Viewer Zero Footprint / ZFP-24825373, 17152365-Centricity Universal Viewer Zero Footprint / ZFP-26632357, 17040488-Centricity Universal Viewer Zero Footprint / ZFP-26404455. 2) 2110344-046, UDI/DI 00840682102988, System ID Numbers: 6579-11-Centricity Universal Viewer Zero Footprint / ZFP-26923415, 10458-1-Centricity Universal Viewer Zero Footprint / ZFP-26898336, 3886-4-Centricity Universal Viewer Zero Footprint / ZFP-22180910, 3886-4-Centricity Universal Viewer Zero Footprint / ZFP-22180906, 9094-1-Centricity Universal Viewer Zero Footprint / ZFP-26705438, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-26839308, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-26839310, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-26839311, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-26839312, 2457-1-Centricity Universal Viewer Zero Footprint / ZFP-26839313, 4326-2-Centricity Universal Viewer Zero Footprint / ZFP-26715184, 10190-9-Centricity Universal Viewer Zero Footprint / ZFP-26850722, 4084-1-Centricity Universal Viewer Zero Footprint / ZFP-26747422, 103696-30-Centricity Universal Viewer Zero Footprint / ZFP-21237479, 4204-1-Centricity Universal Viewer Zero Footprint / ZFP-26884848, 4204-1-Centricity Universal Viewer Zero Footprint / ZFP-26884853, 17094888-Centricity Universal Viewer Zero Footprint / ZFP-26918064, 268882-Centricity Universal Viewer Zero Footprint / ZFP-26747414, 268882-Centricity Universal Viewer Zero Footprint / ZFP-26769258, 268882-Centricity Universal Viewer Zero Footprint / ZFP-26769261, 104991-6-Centricity Universal Viewer Zero Footprint / ZFP-24388499, 104991-4-Centricity Universal Viewer Zero Footprint / ZFP-21350494, 104991-6-Centricity Universal Viewer Zero Footprint / ZFP-24388493, 104991-6-Centricity Universal Viewer Zero Footprint / ZFP-24388494, 104991-6-Centricity Universal Viewer Zero Footprint / ZFP-24388495, 104991-6-Centricity Universal Viewer Zero Footprint / ZFP-24388497, 104991-6-Centricity Universal Viewer Zero Footprint / ZFP-24388498, 104991-5-Centricity Universal Viewer Zero Footprint / ZFP-24388490, 104991-5-Centricity Universal Viewer Zero Footprint / ZFP-24388491, 104991-5-Centricity Universal Viewer Zero Footprint / ZFP-24388492, A91901-Centricity Universal Viewer Zero Footprint / ZFP-24484469, 145790 - HC0399-Centricity Universal Viewer Zero Footprint / ZFP-24374380, HC0014-Centricity Universal Viewer Zero Footprint / ZFP-21359919, 255473-Centricity Universal Viewer Zero Footprint / ZFP-26865306, JP-280250-Centricity Universal Viewer Zero Footprint / ZFP-26671908, JP-283699-Centricity Universal Viewer Zero Footprint / ZFP-26689509, JP-280250-Centricity Universal Viewer Zero Footprint / ZFP-02360544, JP-272375-Centricity Universal Viewer Zero Footprint / ZFP-26918260, 347891-Centricity Universal Viewer Zero Footprint / ZFP-23297397, 347891-Centricity Universal Viewer Zero Footprint / ZFP-26880666, 17195358-Centricity Universal Viewer Zero Footprint / ZFP-23986377, RU1086-Centricity Universal Viewer Zero Footprint / ZFP-26799525, RU1282-Centricity Universal Viewer Zero Footprint / ZFP-26800953, 17121345-Centricity Universal Viewer Zero Footprint / ZFP-26796880, RU8902-Centricity Universal Viewer Zero Footprint / ZFP-17775055, SA2591-Centricity Universal Viewer Zero Footprint / ZFP-26880655, 521920-Centricity Universal Viewer Zero Footprint / ZFP-26912759, 659749-Centricity Universal Viewer Zero Footprint / ZFP-26824375, ZA2239-Centricity Universal Viewer Zero Footprint / ZFP-26805562, 16959088-Centricity Universal Viewer Zero Footprint / ZFP-26777223, GEX184-Centricity Universal Viewer Zero Footprint / ZFP-26368616, 242833-Centricity Universal Viewer Zero Footprint / ZFP-26825072, 80182-Centricity Universal Viewer Zero Footprint / ZFP-26876144, 16882165-Centricity Universal Viewer Zero Footprint / ZFP-26673881, 16880927-Centricity Universal Viewer Zero Footprint / ZFP-26818090. 3) 2110344-047, UDI/DI 00840682102988, System ID Numbers: Local DB site#000330-Centricity Universal Viewer Zero Footprint / ZFP-22138067, Local DB site#000330-Centricity Universal Viewer Zero Footprint / ZFP-22138066, JP-341108-Centricity Universal Viewer Zero Footprint / ZFP-25012607, JP-220062-Centricity Universal Viewer Zero Footprint / ZFP-24475044.

Distribution

Worldwide distribution - US Nationwide and the countries of Belarus, Brazil, Canada, China, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Lebanon, Malaysia, Netherlands, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkiye, United Arab Emirates, United Kingdom, Vietnam.

Quantity

250 units