Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer i...
FDA Device Recall #Z-2102-2018 — Class II — January 25, 2018
Recall Summary
| Recall Number | Z-2102-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 25, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare |
| Location | Chicago, IL |
| Product Type | Devices |
| Quantity | 252 |
Product Description
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 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.
Reason for Recall
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, Panama, Poland, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdomand Uruguay
Lot / Code Information
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
Other Recalls from GE Healthcare
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1475-2026 | Class II | GE Healthcare Centricity Universal Viewer Zero ... | Jan 16, 2026 |
| Z-1487-2025 | Class II | GE Healthcare Centricity Centricity PACS-IW wit... | Feb 19, 2025 |
| Z-1484-2025 | Class II | GE Healthcare Centricity PACS-IW (PACS-IW), Mod... | Feb 19, 2025 |
| Z-1486-2025 | Class II | GE Healthcare Centricity Cardiology CA1000 (CA1... | Feb 19, 2025 |
| Z-1485-2025 | Class II | GE Healthcare Centricity Radiology RA600 (RA600... | Feb 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.