GE Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0140-2024)

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

Class II

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

UDI/DI 840682103800, Installed Product ID #: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Universal Viewer-02157634, 1011-1-Centricity Universal Viewer-00558109, 1011-1-Centricity Universal Viewer-02097166, 1011-1-Centricity Universal Viewer-02097165, 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 9789-1-Centricity Universal Viewer-00558645, 4413-2-Centricity Universal Viewer-02288447, 4267-5-Centricity Universal Viewer-19618406, 100763-1-Centricity Universal Viewer-00558366, 101171-1-Centricity Universal Viewer-02398531, 101171-1-Centricity Universal Viewer-02398531, 104535-3-Centricity Universal Viewer-02396026, 104535-3-Centricity Universal Viewer-02396027, 104535-3-Centricity Universal Viewer-02396028, 104535-3-Centricity Universal Viewer-02396029, 11438-1-Centricity Universal Viewer-00558464, 104535-4-Centricity Universal Viewer-02396030, 104535-4-Centricity Universal Viewer-01806096, 4415-1-Centricity Universal Viewer-00558359, 4415-1-Centricity Universal Viewer-01973510, 4308-1-Centricity Universal Viewer-00558676, 4308-1-Centricity Universal Viewer-21200827, 4308-1-Centricity Universal Viewer-21200830, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 4048-1-Centricity Universal Viewer-00558695, 4048-1-Centricity Universal Viewer-14767809, 4048-1-Centricity Universal Viewer-14767808, 4048-1-Centricity Universal Viewer-14767807, 4048-1-Centricity Universal Viewer-14767806, 4048-1-Centricity Universal Viewer-02256595, 4460-1-Centricity Universal Viewer-02255583, 4460-1-Centricity Universal Viewer-01819618, 4460-7-Centricity Universal Viewer-02255586, 4460-7-Centricity Universal Viewer-02255587, 101280-1-Centricity Universal Viewer-19630914, 101280-1-Centricity Universal Viewer-19630915, 101280-1-Centricity Universal Viewer-19630916, 101280-1-Centricity Universal Viewer-20553950, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4552-1-Centricity Universal Viewer-01294074, 6579-11-Centricity Universal Viewer-02339896, 4353-2-Centricity Universal Viewer-01589220, 4698-1-Centricity Universal Viewer-00558313, 100029-1-Centricity Universal Viewer-02256808, 100717-1-Centricity Universal Viewer-01293807, 100717-1-Centricity Universal Viewer-01293808, 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 100019-1-Centricity Universal Viewer-00558666, 100019-1-Centricity Universal Viewer-01477448, 100019-1-Centricity Universal Viewer-01477447, 100019-1-Centricity Universal Viewer-15993728, 101725-2-Centricity Universal Viewer-00558642, 4687-1-Centricity Universal Viewer-00558334, 100489-1-Centricity Universal Viewer-01819402, 100489-1-Centricity Universal Viewer-20791988, 104249-1-Centricity Universal Viewer-00558667, 104287-2-Centricity Universal Viewer-00555505, 4451-1-Centricity Universal Viewer-00558107, 100366-1-Centricity Universal Viewer-00558522, 100366-1-Centricity Universal Viewer-14777071, 100718-2-Centricity Universal Viewer-02350739, 100718-1-Centricity Universal Viewer-02373799, 4742-2-Centricity Universal Viewer-01766912, 4742-2-Centricity Universal Viewer-20584004, 4742-2-Centricity Universal Viewer-20685485, 4583-1-Centricity Universal Viewer-01367198, 12968-1-Centricity Universal Viewer-02277843, 12968-1-Centricity Universal Viewer-02278145, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 12902-1-Centricity Universal Viewer-00602638, 3245-1-Centricity Universal Viewer-01451973, 4585-3-Centricity Universal Viewer-01448365, 4585-3-Centricity Universal Viewer-20502096, 101039-1-Centricity Universal Viewer-01373579, 101039-1-Centricity Universal Viewer-14580319, 13345-1-Centricity Universal Viewer-00602707, 9852-2-Centricity Universal Viewer-00558644, 9852-2-Centricity Universal Viewer-02267839, 9852-2-Centricity Universal Viewer-01271417, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 9764-1-Centricity Universal Viewer-01722652, 4391-1-Centricity Universal Viewer-02205222, 4391-3-Centricity Universal Viewer-01459013, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 100159-1-Centricity Universal Viewer-00558324, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 101598-1-Centricity Universal Viewer-00667138, 100971-1-Centricity Universal Viewer-00558469, 4382-1-Centricity Universal Viewer-02268547, 102768-1-Centricity Universal Viewer-02179353, 102768-1-Centricity Universal Viewer-02255613, 102768-1-Centricity Universal Viewer-16174584, 100636-1-Centricity Universal Viewer-01815255, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 9094-1-Centricity Universal Viewer-01766830, 9094-1-Centricity Universal Viewer-01977629, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 4682-1-Centricity Universal Viewer-02274840, 100864-1-Centricity Universal Viewer-00558400, 4669-1-Centricity Universal Viewer-00558691, 4669-1-Centricity Universal Viewer-14768587, 100104-1-Centricity Universal Viewer-16204735, 100104-1-Centricity Universal Viewer-01299102, 4440-1-Centricity Universal Viewer-00558353, 4440-1-Centricity Universal Viewer-02332746, 104491-1-Centricity Universal Viewer-01288014, 12961-1-Centricity Universal Viewer-00558236, 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478, 4305-7-Centricity Universal Viewer-16204605, 4305-7-Centricity Universal Viewer-16204606, 4305-7-Centricity Universal Viewer-16204607, 4305-7-Centricity Universal Viewer-16204608, 4305-7-Centricity Universal Viewer-16204609, 4305-7-Centricity Universal Viewer-16204612, 4305-7-Centricity Universal Viewer-16204613, 4306-3-Centricity Universal Viewer-00558573, 4306-1-Centricity Universal Viewer-02263351, 4306-3-Centricity Universal Viewer-02345023, 4306-3-Centricity Universal Viewer-02288781, 4362-1-Centricity Universal Viewer-01299095, 4362-1-Centricity Universal Viewer-19732280, 100581-1-Centricity Universal Viewer-01814001, 100092-1-Centricity Universal Viewer-15531177, 100092-1-Centricity Universal Viewer-14767331, 100092-1-Centricity Universal Viewer-00558648, 100092-1-Centricity Universal Viewer-00558697, 8746-1-Centricity Universal Viewer-00558308, 8746-1-Centricity Universal Viewer-01448329, 1057-1-Centricity Universal Viewer-02180910, 1057-1-Centricity Universal Viewer-00558402, 1057-1-Centricity Universal Viewer-14961014, 104336-1-Centricity Universal Viewer-00346858, 101690-1-Centricity Universal Viewer-00558680, 101690-1-Centricity Universal Viewer-20091140, 13125-1-Centricity Universal Viewer-00558110, 13125-1-Centricity Universal Viewer-20497227, 4351-1-Centricity Universal Viewer-01627896, 4351-1-Centricity Universal Viewer-16023960, 101170-1-Centricity Universal Viewer-00558305, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, 4742-3-Centricity Universal Viewer-02182462, 9796-1-Centricity Universal Viewer-00558571, 100770-1-Centricity Universal Viewer-01804127, 9752-1-Centricity Universal Viewer-02393053, 9752-1-Centricity Universal Viewer-00558454, 13225-1-Centricity Universal Viewer-02032334, 100769-1-Centricity Universal Viewer-01298556, 100769-1-Centricity Universal Viewer-02395799, 2403-7-Centricity Universal Viewer-01973509, 100468-1-Centricity Universal Viewer-02287985, 100468-1-Centricity Universal Viewer-02288300, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, 4683-1-Centricity Universal Viewer-00558456, 4601-1-Centricity Universal Viewer-00558699, 101310-1-Centricity Universal Viewer-02039946, 4347-1-Centricity Universal Viewer-00558520, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, AH4325-Centricity Universal Viewer-00160202, AH5291-Centricity Universal Viewer-00394902, AP6264-Centricity Universal Viewer-00000180, AP6469-Centricity Universal Viewer-01816421, AH0116-Centricity Universal Viewer-00160203, AH0106-Centricity Universal Viewer-00160204, 613493-Centricity Universal Viewer-02175791, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-02097256, 313741-Centricity Universal Viewer-15591262, 000282202-Centricity Universal Viewer-02291736, 571064-Centricity Universal Viewer-01293639, A54852-Centricity Universal Viewer-00043560, M41980-Centricity Universal Viewer-00044515, HC0399-Centricity Universal Viewer-01282972, PC1695-Centricity Universal Viewer-01447701, 786787-Centricity Universal Viewer-01283171, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, 509940-Centricity Universal Viewer-01813036, HC0529-Centricity Universal Viewer-01364776, 683198-Centricity Universal Viewer-02263377, HC0245-Centricity Universal Viewer-00059319, 600791-Centricity Universal Viewer-02099049, 427990-Centricity Universal Viewer-01813160, 485135-Centricity Universal Viewer-01447706, 2336375-Centricity Universal Viewer-01444341, HC1414-Centricity Universal Viewer-01814335, PC1961-Centricity Universal Viewer-00001720, PC0023-Centricity Universal Viewer-01282279, 531344-Centricity Universal Viewer-00000707, CC0154-Centricity Universal Viewer-01813738, 509585-Centricity Universal Viewer-01826272, 601860-Centricity Universal Viewer-01373156, HC0565-Centricity Universal Viewer-00545595, HC4357-Centricity Universal Viewer-02090320, TP0575-Centricity Universal Viewer-01825777, 81111-Centricity Universal Viewer-01286673, A59927-Centricity Universal Viewer-00040382, A61971-Centricity Universal Viewer-01891850, AMS39-Centricity Universal Viewer-00545606, 268034-Centricity Universal Viewer-18862276, PL3673-Centricity Universal Viewer-00038810, PL1494-Centricity Universal Viewer-00038799, PL2970-Centricity Universal Viewer-00038797, PL1124-Centricity Universal Viewer-00038795, PL1499-Centricity Universal Viewer-00038800, PL1501-Centricity Universal Viewer-00038802, PL1190-Centricity Universal Viewer-21245580, PL1961-Centricity Universal Viewer-01981010, PL2624-Centricity Universal Viewer-00038804, PL1005-Centricity Universal Viewer-02336290, 600062-Centricity Universal Viewer-02095166, PL3362-Centricity Universal Viewer-20631670, PL0326-Centricity Universal Viewer-02040892, PL2975-Centricity Universal Viewer-00162605, PL2971-Centricity Universal Viewer-00038808, RU9255-Centricity Universal Viewer-19727239, RU8414-Centricity Universal Viewer-01445730, RU7519-Centricity Universal Viewer-01816694, RU4255-Centricity Universal Viewer-02331160, RU0003-Centricity Universal Viewer-02335931, RU9059-Centricity Universal Viewer-01445746, RU9327-Centricity Universal Viewer-02337466, RU1011-Centricity Universal Viewer-02330918, RU8366-Centricity Universal Viewer-18045776, RU1112-Centricity Universal Viewer-01453917, RU1112-Centricity Universal Viewer-01977813, RU1112-Centricity Universal Viewer-01980259, RU1516-Centricity Universal Viewer-02331146, RU1717-Centricity Universal Viewer-01476628, RU0472-Centricity Universal Viewer-02092677, RU3052-Centricity Universal Viewer-02330856, RU1107-Centricity Universal Viewer-01813331, RU9216-Centricity Universal Viewer-01982768, 600101-Centricity Universal Viewer-01273190, RU1544-Centricity Universal Viewer-02330871, RU2526-Centricity Universal Viewer-02331246, RU5388-Centricity Universal Viewer-01719556, RU0994-Centricity Universal Viewer-02331254, RU3794-Centricity Universal Viewer-19673911, RU9226-Centricity Universal Viewer-19673912, RU6968-Centricity Universal Viewer-02335840, RU8356-Centricity Universal Viewer-01445768, RU9595-Centricity Universal Viewer-01812133, 600105-Centricity Universal Viewer-02331152, RU9697-Centricity Universal Viewer-19673913, 2422939-Centricity Universal Viewer-01509505, RU0120-Centricity Universal Viewer-02335932, RU9546-Centricity Universal Viewer-01812747, RU3998-Centricity Universal Viewer-01553790, RU6164-Centricity Universal Viewer-19720917, SA1339-Centricity Universal Viewer-00116444, SI4014-Centricity Universal Viewer-01889278, 16218680-Centricity Universal Viewer-02266272, ZA2267-Centricity Universal Viewer-02001877, ZA2541-Centricity Universal Viewer-01985829, ZA2472-Centricity Universal Viewer-00116565, 482896-Centricity Universal Viewer-00545574, 941804-Centricity Universal Viewer-02287043, 85021-Centricity Universal Viewer-01426096, 318055-Centricity Universal Viewer-01457316; UDI/DI none, 4413-2-Centricity Universal Viewer-01300927, 4413-2-Centricity Universal Viewer-01300929, 4267-5-Centricity Universal Viewer-20884363, 4267-5-Centricity Universal Viewer-20884364, 4267-5-Centricity Universal Viewer-20884365, 4446-2-Centricity Universal Viewer-00558643, 4491-1-Centricity Universal Viewer-00558690, 100256-3-Centricity Universal Viewer-00558700, 100256-3-Centricity Universal Viewer-01810788, 102143-1-Centricity Universal Viewer-00558685, 101044-1-Centricity Universal Viewer-00558694, 100837-1-Centricity Universal Viewer-00558435, 100837-1-Centricity Universal Viewer-17594527, 13356-2-Centricity Universal Viewer-00558681, 4379-1-Centricity Universal Viewer-02184891, 102335-1-Centricity Universal Viewer-00558675, 13240-2-Centricity Universal Viewer-00558103, 13228-1-Centricity Universal Viewer-00558678, 101274-1-Centricity Universal Viewer-00558679, 101274-1-Centricity Universal Viewer-20279342, 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 13125-1-Centricity Universal Viewer-02268546, 102359-1-Centricity Universal Viewer-00558696, 4441-1-Centricity Universal Viewer-00558677, 4578-1-Centricity Universal Viewer-00558340, 2403-7-Centricity Universal Viewer-00558347, 11042-1-Centricity Universal Viewer-02285888, 11042-1-Centricity Universal Viewer-19603374, 280801-Centricity Universal Viewer-19737221, A91901-Centricity Universal Viewer-00044549, CC4105-Centricity Universal Viewer-01282278, HC4105-Centricity Universal Viewer-00001393, 233637-Centricity Universal Viewer-15773152, A54120-Centricity Universal Viewer-00040449, KW0000-Centricity Universal Viewer-01416913, BON01-Centricity Universal Viewer-00044131, PL3349-Centricity Universal Viewer-00038811, PL3277-Centricity Universal Viewer-00038831, RU3866-Centricity Universal Viewer-01445731, RU8945-Centricity Universal Viewer-01445740, RU2580-Centricity Universal Viewer-01445743, RU7175-Centricity Universal Viewer-01445748, RU1646-Centricity Universal Viewer-01445763, RU1107-Centricity Universal Viewer-01273207, RU3453-Centricity Universal Viewer-01273249, TBD-Centricity Universal Viewer-01273292, MPX352-Centricity Universal Viewer-19629107, DP7603-Centricity Universal Viewer-20093544, FP5028-Centricity Universal Viewer-00110911, 651948-Centricity Universal Viewer-01813739, 124774-Centricity Universal Viewer-00000208, 237870-Centricity Universal Viewer-01444278

US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam

Voluntary: Firm initiated