Class 2 Device Recall GE Healthcare

• Date Initiated by Firm: January 16, 2026
• Date Posted: February 27, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1475-2026
• Recall Event ID: 98368
• 510(K)Number: K131977
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
• Code Information: 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.
• FEI Number: 3004526608
• Recalling Firm/ Manufacturer: GE Healthcare; 500 W Monroe St; Chicago IL 60661-3671
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: 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,
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 250 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ