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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

GE Healthcare: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.

Agency Publication Date: June 6, 2018
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Affected Products

Product: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images m

102747-1-Centricity Universal Viewer-00558673, 11580-1-Centricity Universal Viewer-00558646, 12945-1-Centricity Universal Viewer-00558658, 103852-1-Centricity Universal Viewer-00116028, 103246-1-Centricity Universal Viewer-00558668, 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 101725-2-Centricity Universal Viewer-00558642, 10227-1-Centricity Universal Viewer-00558665, 9768-1-Centricity Universal Viewer-00558661, 100019-1-Centricity Universal Viewer-00558666, 4284-1-Centricity Universal Viewer-00558672, 101272-1-Centricity Universal Viewer-00558671, 100862-1-Centricity Universal Viewer-01444483, 10278-1-Centricity Universal Viewer-00558655, 9789-1-Centricity Universal Viewer-00558645, 12914-1-Centricity Universal Viewer-00558660, 1696-1-Centricity Universal Viewer-00558659, 4408-1-Centricity Universal Viewer-00558664, 4410-1-Centricity Universal Viewer-00558656, 4407-1-Centricity Universal Viewer-00558657, 4407-1-Centricity Universal Viewer-00558652, 4405-1-Centricity Universal Viewer-00558662, 4546-1-Centricity Universal Viewer-00558670, 100064-1-Centricity Universal Viewer-00558572, 100092-1-Centricity Universal ,Viewer-00558648, 1345-1-Centricity Universal Viewer-00558654, 4705-1-Centricity Universal Viewer-00558663, 4418-1-Centricity Universal Viewer-00558674, 102062-1-Centricity Universal Viewer-00558650, 12866-1-Centricity Universal Viewer-01448215, 101931-1-Centricity Universal Viewer-00558569, 4601-1-Centricity Universal Viewer-00558710, 102406-2-Centricity Universal Viewer-00558669, 102406-2-Centricity Universal Viewer-00558667 A59927-Centricity Universal Viewer-00040382, X13479-Centricity Universal Viewer-00043936, and 269338-Centricity Universal Viewer-01453050, 94767-Centricity Universal Viewer-01422997.

Product: Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be in

102123-1-Centricity Universal Viewer-00558570, 9796-1-Centricity Universal Viewer-00558571, 1011-1-Centricity Universal Viewer-00558109, 4433-1-Centricity Universal Viewer-00558704, 4446-2-Centricity Universal Viewer-00558643, 13240-2-Centricity Universal Viewer-00558103, 4487-1-Centricity Universal Viewer-01291589, 13295-1-Centricity Universal Viewer-01292684, 103090-2-Centricity Universal Viewer-00546048, 3760-1-Centricity Universal Viewer-00101627, 102580-1-Centricity Universal Viewer-00558689, 102143-1-Centricity Universal Viewer-00558685, 4271-1-Centricity Universal Viewer-00558351, 4273-3-Centricity Universal Viewer-00558104, 2440-1-Centricity Universal Viewer-00558701, 100366-1-Centricity Universal Viewer-00558522, 100769-1-Centricity Universal Viewer-01298556, 102278-1-Centricity Universal Viewer-00558682, 3846-3-Centricity Universal Viewer-00111167, 4449-1-Centricity Universal Viewer-00558276, 3245-1-Centricity Universal Viewer-01451973, 101690-1-Centricity Universal Viewer-00558680, 101039-1-Centricity Universal Viewer-01373579, 4451-1-Centricity Universal Viewer-,00558107, 100837-1-Centricity Universal Viewer-00558435, 4583-1-Centricity Universal Viewer-01367198, 13162-8-Centricity Universal Viewer-01452133, 4491-1-Centricity Universal Viewer-00558690, 13296-1-Centricity Universal Viewer-01364047, 9752-1-Centricity Universal Viewer-00558454, 1472-15-Centricity Universal Viewer-01367676, 101044-1-Centricity Universal Viewer-00558694, 13228-1-Centricity Universal Viewer-00558678, 102335-1-Centricity Universal Viewer-00558675, 4369-1-Centricity Universal Viewer-00558705, 4615-1-Centricity Universal Viewer-01452088, 4371-1-Centricity Universal Viewer-00558358, 4289-1-Centricity Universal Viewer-00558459, 101274-1-Centricity Universal Viewer-00558679, 100693-1-Centricity Universal Viewer-00558684, 104491-1-Centricity Universal Viewer-01288014, 1027-1-Centricity Universal Viewer-00558706, 104336-1-Centricity Universal Viewer-00346858, 4578-1-Centricity Universal Viewer-00558340, 13345-1-Centricity Universal Viewer-00602707, 4375-1-Centricity Universal Viewer-00558392, 9852-2-Centricity Universal Viewer-00558644, 101726-1-Centricity Universal Viewer-00558688, 100256-1-Centricity Universal Viewer-00558700, 4308-1-Centricity Universal Viewer-00558676, 100773-1-Centricity Universal Viewer-00558484, 4669-1-Centricity Universal Viewer-00558691, 100159-1-Centricity Universal Viewer-00558324, 4406-1-Centricity Universal Viewer-00558683, 4314-1-Centricity Universal Viewer-00558466, 4318-1-Centricity Universal Viewer-00558703, 102325-1-Centricity Universal Viewer-00558647, 4415-1-Centricity Universal Viewer-00558359, 4585-3-Centricity Universal Viewer-01448365, 4440-1-Centricity Universal Viewer-00558353, 4441-1-Centricity Universal Viewer-00558677, 104558-1-Centricity Universal Viewer-01522793, 4693-1-Centricity Universal Viewer-00558687, 104120-1-Centricity Universal Viewer-00164159, 100717-1-Centricity Universal Viewer-01293807, 4048-1-Centricity Universal Viewer-00558695, 102437-1-Centricity Universal Viewer-00558698, 4698-1-Centricity Universal Viewer-00558313, 13356-2-Centricity Universal Viewer-00558681, 12902-1-Centricity Universal Viewer-00602638, 100614-1-Centricity Universal Viewer-00558693, 4325-51-Centricity Universal Viewer-00599129, 101120-1-Centricity Universal Viewer-00558702, 4483-1-Centricity Universal Viewer-00558457, 102406-2-Centricity Universal Viewer-00558111, 102406-2-Centricity Universal Viewer-00558692, 102406-2-Centricity Universal Viewer-00558686, 102406-2-Centricity Universal Viewer-00558707, 13125-1-Centricity Universal Viewer-00558110, 102693-1-Centricity Universal Viewer-01282651, 101598-1-Centricity Universal Viewer-00667138, 318055-Centricity Universal Viewer-01457316, 85021-Centricity Universal Viewer-01426096, AE1476-Centricity Universal Viewer-01509883, AE1478-Centricity Universal Viewer-00163417, 06051-Centricity Universal Viewer-00115203, 48010-Centricity Universal Viewer-01444602, 34381-Centricity Universal Viewer-00116124, 53008-Centricity Universal Viewer-00116118, 482896-Centricity Universal Viewer-00545574, 228493-Centricity Universal Viewer-00599935, 802030-Centricity Universal Viewer-00000462, 899010-Centricity Universal Viewer-01300907, 123953-Centricity Universal Viewer-00163388, 651948-Centricity Universal Viewer-01813739, YP3150-Centricity Universal Viewer-01639018, FP5028-Centricity Universal Viewer-00110911, ZA00113-Centricity Universal Viewer-01474463, ZA2533-Centricity Universal Viewer-00116577, ZA1058-Centricity Universal Viewer-01724673, ZA2551-Centricity Universal Viewer-00116834, SA1339-Universal Viewer-00116444, RU7175-Centricity Universal Viewer-01445748, RU8414-Centricity Universal Viewer-01445730, RU7808-Centricity Universal Viewer-01445764, RU1745-Centricity Universal Viewer-01445766, RU3998-Centricity Universal Viewer-01553790, SiteID-Centricity Universal Viewer-01509505, RU8002-Centricity PACS-IW-01273292, RU1646-Centricity Universal Viewer-01445763, RU2580-Centricity Universal Viewer-01445743, SiteID-Centricity Universal Viewer-01476628, 600101-Centricity Universal Viewer-01273190, RU8356-Centricity Universal Viewer-01445768, RU9059-Centricity Universal Viewer-01445746, RU1112-Centricity Universal Viewer-01453917, RU3866-Centricity Universal Viewer-01445731, RU3453-Centricity Universal Viewer-01273249, RU1011-Centricity Universal Viewer-01445747, RU1130-Centricity Universal Viewer-01273228, Centricity Universal Viewer-01462487, RU5388-Centricity Universal Viewer-01719556, RU1106-Centricity Universal Viewer-01445765, RU8945-Centricity Universal Viewer-01445740,PL3249-Centricity Universal Viewer-00038866, PL3673-Centricity Universal Viewer-00038810, PL1494-Centricity Universal Viewer-00038799, PL2970-Centricity Universal Viewer-00038797, PL1499-Centricity Universal Viewer-00038800, PL1501-Centricity Universal Viewer-00038802, PL1124-Centricity Universal Viewer-00038795, PL2624-Centricity Universal Viewer-00038804, PL1504-Centricity Universal Viewer-00038806, PL2971-Centricity Universal Viewer-00038808, PL3277-Centricity Universal Viewer-00038831, PL2975-Centricity Universal Viewer-00162605 PL3349-Centricity Universal Viewer-00038811, AMS39-Centricity Universal Viewer-00545606, BON01-Centricity Universal Viewer-00044131, ECT02-Centricity Universal Viewer-00059842, 338896-Centricity PACS-IW-01443491, 329052-Centricity Universal Viewer-01443407, HUSM-Centricity Universal Viewer-01286208, IPPT-Centricity Universal Viewer-01286213, KW1005-Centricity Universal Viewer-01300924, KW0000-Centricity Universal Viewer-01416913, A51911-Centricity Universal Viewer-00040346, A54120-Centricity Universal Viewer-00040449, A3790481-Centricity Universal Viewer-00040932 A3784447-Centricity Universal Viewer-00158569, IL1469-Centricity Universal Viewer-00040970, 81111-Centricity Universal Viewer-01286673, 0000220630II8, 00000230818II7, SiteID-Centricity Universal Viewer-01724675, 434487-Centricity Universal Viewer-01453839, UC2011-Centricity Universal Viewer-01282271, 786787-Centricity Universal Viewer-01283171, PC1961-C-Generic Web Client-00001718, PC1961-Centricity Universal Viewer-00164218, PC1961-Centricity Universal Viewer-00001720, HBON01-Centricity Universal Viewer-00260801, HC9502-Centricity Universal Viewer-00260671, PC1695-Centricity Universal Viewer-01451951, PC1695-Centricity Universal Viewer-01447701, HC0245-Centricity Universal Viewer-00059319, 691749-Centricity Universal Viewer-01539092, HC1642-Centricity Universal Viewer-01634899, HC3062-Centricity Universal Viewer-01462397, HC4105-Centricity Universal Viewer-00001393, CC4105-Centricity Universal Viewer-01282278, 233637-Centricity Universal Viewer-01444341, 485135-Centricity Universal Viewer-01447706, HC0565-Centricity Universal Viewer-00545595, 530366-Centricity Universal Viewer-00260659, PC0023-Centricity Universal Viewer-01282279, PX4900-Centricity Universal Viewer-01369835, 601860-Centricity Universal Viewer-01373156, HC0529-Centricity Universal Viewer-01364776, 531344-Centricity Universal Viewer-00000707, HG1900-Centricity Universal Viewer-01282276, CC0154-Centricity Universal Viewer-01813738, UHAM02-Centricity Universal Viewer-01447361, UHAM02-Centricity Universal Viewer-01447361, M41613-Centricity Universal Viewer-00043666, M44610-Centricity Universal Viewer-00043788, E41676-Centricity Universal Viewer-00043587, X3141198-Centricity Universal Viewer-00043959, M15393-Centricity Universal Viewer-00043611, M41745-Centricity Universal Viewer-00043708, X1413856-Centricity Universal Viewer-00044474, X1982342-Centricity Universal Viewer-00043950, M45006-Centricity Universal Viewer-00043854, M44917-Centricity Universal Viewer-00043845, M46163-Centricity Universal Viewer-00043858, M41765-Centricity Universal Viewer-00043715, A54852-Centricity Universal Viewer-00043560, M41870-Centricity Universal Viewer-00043721, M41894-Centricity Universal Viewer-00043726, M42073-Centricity Universal Viewer-00044530, M60364-Centricity Universal Viewer-01801169, M44875-Centricity Universal Viewer-00043829, M41913-Centricity Universal Viewer-00065993, M41914-Centricity Universal Viewer-00043730, X3041774-Centricity Universal Viewer-00043956, X2015148-Centricity Universal Viewer-00044553, M44599-Centricity Universal Viewer-00043784, M232471-Centricity Universal Viewer-00043629, A91901-Centricity Universal Viewer-00044549, M41980-Centricity Universal Viewer-00044515, M41981-Centricity Universal Viewer-01270561, M41974-Centricity Universal Viewer-00043736, M43605-Centricity Universal Viewer-00043769, M44877-Centricity Universal Viewer-00043766, M44997-Centricity Universal Viewer-00397920, M42176-Centricity Universal Viewer-00043763, A91901-Centricity Universal Viewer-01509889, 339734-Centricity PACS-IW-01444878, 283134-Centricity PACS-01265050, 282927-Centricity Universal Viewer-01806769, 2321223-Centricity Universal Viewer-01476150, 571064-Centricity Universal Viewer-01293639, 268882-Centricity Universal Viewer-01422969, 190171-Centricity Universal Viewer-00044015, 300013-Centricity Universal Viewer-00156933, AH4325-Centricity Universal Viewer-00160202, AH0116-Centricity Universal Viewer-00160203, AH0106-Centricity Universal Viewer-00160204, AP6264-Centricity Universal Viewer-00000180, 102359-1-Centricity Universal Viewer-00558696, 4306-1-Centricity Universal Viewer-00558573, 124774-Centricity Universal Viewer-00110991, RU1107-Centricity Universal Viewer-01273207, and HC0529-Centricity Universal Viewer-01364775

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80159
Status: Resolved
Manufacturer: GE Healthcare
Manufactured In: United States
Units Affected: 2 products (44; 252)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.