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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1475-2026
Recalling firm
GE Healthcare
Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Status
Open, Classified
Initiated
2026-01-16
Posted
2026-02-27
Terminated
not on file
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,
Root 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
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.
Lot, serial or model codes
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.
510(k) numbers
["K131977"]
PMA numbers
not on file
Product code
LLZ
Firm FEI
3004526608
Firm city
Chicago
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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