Reported Jun 13, 2018 · Terminated

Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays…

GE Healthcare

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare · 500 W Monroe St · Chicago, IL · 60661-3671

Is this the product you have?

  • Centricity
  • Universal Viewer Product UsageUsage: 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 interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants
Lot codes and dates
  • 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
Amount recalled
252

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 2, 2023 · Data as of Sep 19, 6:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.