Device product
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Z-0140-2024
Product summary
- Firm
- GE Healthcare
- Event
- Event 93099
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 329 units
- Official record key
device-enforcement:Z-0140-2024
Official wording
Reason: 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.
Code information: 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
Distribution pattern: 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
Derived failure modes
-
Unknown
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.