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Centricity recallZ-1501-2023 · GE Healthcare · initiated Mar 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Other

What the company is doing

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.

Recall details

Recall number
Z-1501-2023
Status
Open, Classified
Initiated by the company
Mar 28, 2023
Posted by the FDA
May 2, 2023
Recalling firm
GE Healthcare
Quantity
329 units
Product code
LLZ
FDA submissions
K150420
Distribution
Worldwide Distribution

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (16k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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