Z-1501-2023Class II
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b)...
GE Healthcare / initiated 2023-03-28 / Open, Classified
GE Healthcare began a recall of Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e)... on . FDA classified it as Class II and gives the reason as "GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1501-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- GE Healthcare
- Product
- Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System
- Product code
- LLZ System, Image Processing, Radiological
- Reason for recall
- GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- FDA root cause
- Other
- Action
- GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.
- Quantity in commerce
- 329 units
- Distribution
- Worldwide Distribution
- Product codes and lots
- a) 2088026-003, No UDI/DI, Product ID numbers: 233637-Centricity Universal Viewer-15773152; b) 2088026-026, No UDI/DI, Product ID numbers: 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, 13356-2-Centricity Universal Viewer-00558681, 102335-1-Centricity Universal Viewer-00558675, 13228-1-Centricity Universal Viewer-00558678, 101274-1-Centricity Universal Viewer-00558679, 101274-1-Centricity Universal Viewer-20279342, 13125-1-Centricity Universal Viewer-02268546, 102359-1-Centricity Universal Viewer-00558696, 4578-1-Centricity Universal Viewer-00558340, A54120-Centricity Universal Viewer-00040449, KW0000-Centricity Universal Viewer-01416913, BON01-Centricity Universal Viewer-00044131, PL3277-Centricity Universal Viewer-00038831; c) 2088026-032, No UDI/DI, Product ID numbers: 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 124774-Centricity Universal Viewer-00000208; d) 2088026-043, No UDI/DI, Product ID numbers: 4441-1-Centricity Universal Viewer-00558677, PL3349-Centricity Universal Viewer-00038811, 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, RU3453-Centricity Universal Viewer-01273249, TBD-Centricity Universal Viewer-01273292; e) 2088026-044, No UDI/DI, Product ID numbers: 237870-Centricity Universal Viewer-01444278; f) 2088026-115, No UDI/DI, Product ID numbers: 4413-2-Centricity Universal Viewer-01300927, 4413-2-Centricity Universal Viewer-01300929, 100837-1-Centricity Universal Viewer-00558435, 100837-1-Centricity Universal Viewer-17594527, 13240-2-Centricity Universal Viewer-00558103, 11042-1-Centricity Universal Viewer-02285888, 11042-1-Centricity Universal Viewer-19603374; g) 2088026-132, No UDI/DI, Product ID numbers: A91901-Centricity Universal Viewer-00044549, CC4105-Centricity Universal Viewer-01282278, HC4105-Centricity Universal Viewer-00001393, 651948-Centricity Universal Viewer-01813739; h) 2088026-306, UDI/DI840682103800, Product ID numbers: 11438-1-Centricity Universal Viewer-00558464, 101280-1-Centricity Universal Viewer-19630915, ZA2541-Centricity Universal Viewer-01985829, ZA2472-Centricity Universal Viewer-00116565; i) 2088026-308, UDI/DI 840682103800, Product ID numbers: 4267-5-Centricity Universal Viewer-19618406, 100763-1-Centricity Universal Viewer-00558366, 101280-1-Centricity Universal Viewer-19630914, 101280-1-Centricity Universal Viewer-19630916, 101280-1-Centricity Universal Viewer-20553950, 4451-1-Centricity Universal Viewer-00558107, 101170-1-Centricity Universal Viewer-00558305, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, PL2975-Centricity Universal Viewer-00162605, 318055-Centricity Universal Viewer-01457316, 4267-5-Centricity Universal Viewer-20884363, 4267-5-Centricity Universal Viewer-20884364, 4267-5-Centricity Universal Viewer-20884365; j) 2088026-406, UDI/DI 840682103800, Product ID numbers: 4552-1-Centricity Universal Viewer-01294074, 100029-1-Centricity Universal Viewer-02256808, 100717-1-Centricity Universal Viewer-01293807, 100717-1-Centricity Universal Viewer-01293808, 13345-1-Centricity Universal Viewer-00602707, 8746-1-Centricity Universal Viewer-01448329, 4683-1-Centricity Universal Viewer-00558456, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, 571064-Centricity Universal Viewer-01293639, 786787-Centricity Universal Viewer-01283171; k) 2088026-506, UDI/DI 840682103800, Product ID numbers: 9094-1-Centricity Universal Viewer-01766830, 100770-1-Centricity Universal Viewer-01804127, 313741-Centricity Universal Viewer-02097256, 268034-Centricity Universal Viewer-18862276, RU1107-Centricity Universal Viewer-01813331, RU5388-Centricity Universal Viewer-01719556, 16218680-Centricity Universal Viewer-02266272, ZA2267-Centricity Universal Viewer-02001877; l) 2088026-613, UDI/DI 840682103800, Product ID numbers: 1011-1-Centricity Universal Viewer-00558109, 1011-1-Centricity Universal Viewer-02097166, 1011-1-Centricity Universal Viewer-02097165, 100159-1-Centricity Universal Viewer-00558324, 101598-1-Centricity Universal Viewer-00667138, 104491-1-Centricity Universal Viewer-01288014; m) 2088026-713, No UDI/DI, Product ID numbers: 2403-7-Centricity Universal Viewer-00558347, RU1107-Centricity Universal Viewer-01273207, MPX352-Centricity Universal Viewer-19629107, DP7603-Centricity Universal Viewer-20093544, FP5028-Centricity Universal Viewer-00110911; UDI/DI 840682103800, Product ID numbers: 4362-1-Centricity Universal Viewer-01299095, 4362-1-Centricity Universal Viewer-19732280, HC0399-Centricity Universal Viewer-01282972, 509585-Centricity Universal Viewer-01826272, 81111-Centricity Universal Viewer-01286673, AMS39-Centricity Universal Viewer-00545606, 85021-Centricity Universal Viewer-01426096; n) 2088026-714, No UDI/DI, Product ID numbers: 4379-1-Centricity Universal Viewer-02184891; UDI/DI 840682103800, Product ID numbers: 101690-1-Centricity Universal Viewer-20091140, 531344-Centricity Universal Viewer-00000707; o) 2088026-723, UDI/DI 840682103800, Product ID numbers: 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 4415-1-Centricity Universal Viewer-01973510, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4353-2-Centricity Universal Viewer-01589220, 4698-1-Centricity Universal Viewer-00558313, 101725-2-Centricity Universal Viewer-00558642, 4687-1-Centricity Universal Viewer-00558334, 100366-1-Centricity Universal Viewer-00558522, 100366-1-Centricity Universal Viewer-14777071, 100718-2-Centricity Universal Viewer-02350739, 100718-1-Centricity Universal Viewer-02373799, 12968-1-Centricity Universal Viewer-02277843, 12968-1-Centricity Universal Viewer-02278145, 9852-2-Centricity Universal Viewer-00558644, 9852-2-Centricity Universal Viewer-02267839, 9852-2-Centricity Universal Viewer-01271417, 4391-1-Centricity Universal Viewer-02205222, 4391-3-Centricity Universal Viewer-01459013, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 4382-1-Centricity Universal Viewer-02268547, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 4669-1-Centricity Universal Viewer-00558691, 4669-1-Centricity Universal Viewer-14768587, 12961-1-Centricity Universal Viewer-00558236, 4306-3-Centricity Universal Viewer-00558573, 4306-1-Centricity Universal Viewer-02263351, 4306-3-Centricity Universal Viewer-02345023, 4306-3-Centricity Universal Viewer-02288781, 100092-1-Centricity Universal Viewer-15531177, 100092-1-Centricity Universal Viewer-14767331, 100092-1-Centricity Universal Viewer-00558648, 100092-1-Centricity Universal Viewer-00558697, 1057-1-Centricity Universal Viewer-02180910, 1057-1-Centricity Universal Viewer-00558402, 1057-1-Centricity Universal Viewer-14961014, 101690-1-Centricity Universal Viewer-00558680, 9796-1-Centricity Universal Viewer-00558571, 9752-1-Centricity Universal Viewer-02393053, 9752-1-Centricity Universal Viewer-00558454, 100468-1-Centricity Universal Viewer-02287985, 100468-1-Centricity Universal Viewer-02288300, 101310-1-Centricity Universal Viewer-02039946, AP6264-Centricity Universal Viewer-00000180, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-15591262, 000282202-Centricity Universal Viewer-02291736, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, 509940-Centricity Universal Viewer-01813036, HC0529-Centricity Universal Viewer-01364776, HC0245-Centricity Universal Viewer-00059319, 600791-Centricity Universal Viewer-02099049, HC1414-Centricity Universal Viewer-01814335, PC0023-Centricity Universal Viewer-01282279, CC0154-Centricity Universal Viewer-01813738, 601860-Centricity Universal Viewer-01373156, HC0565-Centricity Universal Viewer-00545595, HC4357-Centricity Universal Viewer-02090320, PL1190-Centricity Universal Viewer-21245580, 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, 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, 600101-Centricity Universal Viewer-01273190, RU1544-Centricity Universal Viewer-02330871, RU2526-Centricity Universal Viewer-02331246, RU0994-Centricity Universal Viewer-02331254, RU3794-Centricity Universal Viewer-19673911, RU9226-Centricity Universal Viewer-19673912, RU8356-Centricity Universal Viewer-01445768, 600105-Centricity Universal Viewer-02331152, RU9697-Centricity Universal Viewer-19673913, 2422939-Centricity Universal Viewer-01509505, RU3998-Centricity Universal Viewer-01553790, 482896-Centricity Universal Viewer-00545574, 941804-Centricity Universal Viewer-02287043, 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; p) 2099714-001, UDI/DI 840682103800, Product ID numbers: 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478; q) 2100169-001, UDI/DI 840682103800, Product ID numbers: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Universal Viewer-02157634, 4415-1-Centricity Universal Viewer-00558359, 104287-2-Centricity Universal Viewer-00555505, 4583-1-Centricity Universal Viewer-01367198, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 12902-1-Centricity Universal Viewer-00602638, 4585-3-Centricity Universal Viewer-01448365, 4585-3-Centricity Universal Viewer-20502096, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 100971-1-Centricity Universal Viewer-00558469, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 8746-1-Centricity Universal Viewer-00558308, 2403-7-Centricity Universal Viewer-01973509, 4347-1-Centricity Universal Viewer-00558520; r) 2100491-006, UDI/DI 840682103800, Product ID numbers: 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 3245-1-Centricity Universal Viewer-01451973, 100864-1-Centricity Universal Viewer-00558400, 100769-1-Centricity Universal Viewer-01298556, 100769-1-Centricity Universal Viewer-02395799, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, RU8366-Centricity Universal Viewer-18045776, RU9595-Centricity Universal Viewer-01812133, RU9546-Centricity Universal Viewer-01812747; s) 2102675-010, UDI/DI 840682103800, Product ID numbers: PC1695-Centricity Universal Viewer-01447701, PC1961-Centricity Universal Viewer-00001720, SA1339-Centricity Universal Viewer-00116444; t) 2102676-001, UDI/DI 840682103800, Product ID numbers: 100104-1-Centricity Universal Viewer-16204735, 100104-1-Centricity Universal Viewer-01299102, 104336-1-Centricity Universal Viewer-00346858, M41980-Centricity Universal Viewer-00044515, 427990-Centricity Universal Viewer-01813160, 485135-Centricity Universal Viewer-01447706, 2336375-Centricity Universal Viewer-01444341, A59927-Centricity Universal Viewer-00040382, 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, PL2624-Centricity Universal Viewer-00038804, PL1005-Centricity Universal Viewer-02336290, 600062-Centricity Universal Viewer-02095166, PL0326-Centricity Universal Viewer-02040892, PL2971-Centricity Universal Viewer-00038808, RU6968-Centricity Universal Viewer-02335840, 4601-1-Centricity Universal Viewer-00558699; u) 2104867-044, UDI/DI 840682103800, Product ID numbers: 9789-1-Centricity Universal Viewer-00558645, 4413-2-Centricity Universal Viewer-02288447, 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, 104535-4-Centricity Universal Viewer-02396030, 104535-4-Centricity Universal Viewer-01806096, 4308-1-Centricity Universal Viewer-00558676, 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, 100019-1-Centricity Universal Viewer-00558666, 100019-1-Centricity Universal Viewer-01477448, 100019-1-Centricity Universal Viewer-01477447, 100019-1-Centricity Universal Viewer-15993728, 100489-1-Centricity Universal Viewer-01819402, 100489-1-Centricity Universal Viewer-20791988, 104249-1-Centricity Universal Viewer-00558667, 4742-2-Centricity Universal Viewer-01766912, 101039-1-Centricity Universal Viewer-01373579, 101039-1-Centricity Universal Viewer-14580319, 9764-1-Centricity Universal Viewer-01722652, 102768-1-Centricity Universal Viewer-02179353, 102768-1-Centricity Universal Viewer-02255613, 102768-1-Centricity Universal Viewer-16174584, 100636-1-Centricity Universal Viewer-01815255, 9094-1-Centricity Universal Viewer-01977629, 4682-1-Centricity Universal Viewer-02274840, 4440-1-Centricity Universal Viewer-00558353, 4440-1-Centricity Universal Viewer-02332746, 100581-1-Centricity Universal Viewer-01814001, 13125-1-Centricity Universal Viewer-00558110, 13125-1-Centricity Universal Viewer-20497227, 4351-1-Centricity Universal Viewer-01627896, 4351-1-Centricity Universal Viewer-16023960, 4742-3-Centricity Universal Viewer-02182462, 13225-1-Centricity Universal Viewer-02032334, 613493-Centricity Universal Viewer-02175791, 683198-Centricity Universal Viewer-02263377, TP0575-Centricity Universal Viewer-01825777, A61971-Centricity Universal Viewer-01891850, PL1961-Centricity Universal Viewer-01981010, PL3362-Centricity Universal Viewer-20631670, RU9255-Centricity Universal Viewer-19727239, RU9216-Centricity Universal Viewer-01982768, RU0120-Centricity Universal Viewer-02335932, RU6164-Centricity Universal Viewer-19720917, SI4014-Centricity Universal Viewer-01889278, 101171-1-Centricity Universal Viewer-02398531, 4308-1-Centricity Universal Viewer-21200827, 4308-1-Centricity Universal Viewer-21200830, 6579-11-Centricity Universal Viewer-02339896, 4742-2-Centricity Universal Viewer-20584004, 4742-2-Centricity Universal Viewer-20685485; v) 2104867-045, UDI/DI 840682103800, Product ID numbers: AH4325-Centricity Universal Viewer-00160202, AH5291-Centricity Universal Viewer-00394902, AP6469-Centricity Universal Viewer-01816421, AH0116-Centricity Universal Viewer-00160203, AH0106-Centricity Universal Viewer-00160204, A54852-Centricity Universal Viewer-00043560.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1500-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1501-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1502-2023 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.