—#218475

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K131977
Affected lot / 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.

Why it was recalled

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,

Root cause (FDA determination)

Device Design

Action the firm took

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 01/16/2026 by letter delivered via traceable means. The notice explained the issue and risk, and requested the following: Actions to be taken by Customer/User: "To determine whether you have ZFP Patient Timeline configured at your site, please contact your site administrator. " If you do not have the ZFP Patient Timeline, you can continue to use Centricity Universal Viewer Zero Footprint Client (ZFP) DICOM viewer." "Review all patient studies that were reviewed using the ZFP Patient Timeline to ensure the correct images were reviewed for each patient. GE HealthCare recommends that you discontinue the use of ZFP Patient Timeline." If you do have the ZFP Patient Timeline, pending correction by GE HealthCare, please follow the instructions below: If your site requires the use of Patient Timeline, the following steps must be followed each time a different patient is loaded to ensure the proper series is displayed for this patient: 1. Change the layout to single viewport by selecting the Full view in the Layout Selector (User Manual Section 2.5.1). 2. Manually drag and drop the series from the Navigator into the viewport (User Manual Section 2.4.1). GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare
Address: 500 W Monroe St, Chicago, Illinois 60661-3671

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2026-01-16
Posted by FDA: 2026-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.