CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Centricity Universal Viewer recalled by GE Healthcare
GE Healthcare is recalling Centricity Universal Viewer. The recall was initiated on 14 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0140-2024
- FDA event ID
- 93099
- Recalling firm
- GE Healthcare, Chicago, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Sep 2023
- FDA classified
- 20 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 14 Sep 2023 | Recall initiated by company | |
| 20 Oct 2023 | Classified by FDA | +36 days |
| 1 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Where it was distributed
US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam
Questions about this recall
Is Centricity Universal Viewer recalled?
Yes. GE Healthcare recalled Centricity Universal Viewer on 14 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0140-2024.
Why was it recalled?
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Which lots are affected?
UDI/DI 840682103800, Installed Product ID #: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Universal Viewer-02157634, 1011-1-Centricity Universal Viewer-00558109, 1011-1-Centricity Universal Viewer-02097166, 1011-1-Centricity Universal Viewer-02097165, 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 9789-1-Centricity Universal Viewer-00558645, 4413-2-Centricity Universal Viewer-02288447, 4267-5-Centricity Universal Viewer-19618406, 100763-1-Centricity Universal Viewer-00558366, 101171-1-Centricity Universal Viewer-02398531, 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, 11438-1-Centricity Universal Viewer-00558464, 104535-4-Centricity Universal Viewer-02396030, 104535-4-Centricity Universal Viewer-01806096, 4415-1-Centricity Universal Viewer-00558359, 4415-1-Centricity Universal Viewer-01973510, 4308-1-Centricity Universal Viewer-00558676, 4308-1-Centricity Universal Viewer-21200827, 4308-1-Centricity Universal Viewer-21200830, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 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, 101280-1-Centricity Universal Viewer-19630914, 101280-1-Centricity Universal Viewer-19630915, 101280-1-Centricity Universal Viewer-19630916, 101280-1-Centricity Universal Viewer-20553950, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4552-1-Centricity Universal Viewer-01294074, 6579-11-Centricity Universal Viewer-02339896, 4353-2-Centricity Universal Viewer-01589220, 4698-1-Centricity Universal Viewer-00558313, 100029-1-Centricity Universal Viewer-02256808, 100717-1-Centricity Universal Viewer-01293807, 100717-1-Centricity Universal Viewer-01293808, 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 100019-1-Centricity Universal Viewer-00558666, 100019-1-Centricity Universal Viewer-01477448, 100019-1-Centricity Universal Viewer-01477447, 100019-1-Centricity Universal Viewer-15993728, 101725-2-Centricity Universal Viewer-00558642, 4687-1-Centricity Universal Viewer-00558334, 100489-1-Centricity Universal Viewer-01819402, 100489-1-Centricity Universal Viewer-20791988, 104249-1-Centricity Universal Viewer-00558667, 104287-2-Centricity Universal Viewer-00555505, 4451-1-Centricity Universal Viewer-00558107, 100366-1-Centricity Universal Viewer-00558522, 100366-1-Centricity Universal Viewer-14777071, 100718-2-Centricity Universal Viewer-02350739, 100718-1-Centricity Universal Viewer-02373799, 4742-2-Centricity Universal Viewer-01766912, 4742-2-Centricity Universal Viewer-20584004, 4742-2-Centricity Universal Viewer-20685485, 4583-1-Centricity Universal Viewer-01367198, 12968-1-Centricity Universal Viewer-02277843, 12968-1-Centricity Universal Viewer-02278145, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 12902-1-Centricity Universal Viewer-00602638, 3245-1-Centricity Universal Viewer-01451973, 4585-3-Centricity Universal Viewer-01448365, 4585-3-Centricity Universal Viewer-20502096, 101039-1-Centricity Universal Viewer-01373579, 101039-1-Centricity Universal Viewer-14580319, 13345-1-Centricity Universal Viewer-00602707, 9852-2-Centricity Universal Viewer-00558644, 9852-2-Centricity Universal Viewer-02267839, 9852-2-Centricity Universal Viewer-01271417, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 9764-1-Centricity Universal Viewer-01722652, 4391-1-Centricity Universal Viewer-02205222, 4391-3-Centricity Universal Viewer-01459013, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 100159-1-Centricity Universal Viewer-00558324, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 101598-1-Centricity Universal Viewer-00667138, 100971-1-Centricity Universal Viewer-00558469, 4382-1-Centricity Universal Viewer-02268547, 102768-1-Centricity Universal Viewer-02179353, 102768-1-Centricity Universal Viewer-02255613, 102768-1-Centricity Universal Viewer-16174584, 100636-1-Centricity Universal Viewer-01815255, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 9094-1-Centricity Universal Viewer-01766830, 9094-1-Centricity Universal Viewer-01977629, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 4682-1-Centricity Universal Viewer-02274840, 100864-1-Centricity Universal Viewer-00558400, 4669-1-Centricity Universal Viewer-00558691, 4669-1-Centricity Universal Viewer-14768587, 100104-1-Centricity Universal Viewer-16204735, 100104-1-Centricity Universal Viewer-01299102, 4440-1-Centricity Universal Viewer-00558353, 4440-1-Centricity Universal Viewer-02332746, 104491-1-Centricity Universal Viewer-01288014, 12961-1-Centricity Universal Viewer-00558236, 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478, 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, 4306-3-Centricity Universal Viewer-00558573, 4306-1-Centricity Universal Viewer-02263351, 4306-3-Centricity Universal Viewer-02345023, 4306-3-Centricity Universal Viewer-02288781, 4362-1-Centricity Universal Viewer-01299095, 4362-1-Centricity Universal Viewer-19732280, 100581-1-Centricity Universal Viewer-01814001, 100092-1-Centricity Universal Viewer-15531177, 100092-1-Centricity Universal Viewer-14767331, 100092-1-Centricity Universal Viewer-00558648, 100092-1-Centricity Universal Viewer-00558697, 8746-1-Centricity Universal Viewer-00558308, 8746-1-Centricity Universal Viewer-01448329, 1057-1-Centricity Universal Viewer-02180910, 1057-1-Centricity Universal Viewer-00558402, 1057-1-Centricity Universal Viewer-14961014, 104336-1-Centricity Universal Viewer-00346858, 101690-1-Centricity Universal Viewer-00558680, 101690-1-Centricity Universal Viewer-20091140, 13125-1-Centricity Universal Viewer-00558110, 13125-1-Centricity Universal Viewer-20497227, 4351-1-Centricity Universal Viewer-01627896, 4351-1-Centricity Universal Viewer-16023960, 101170-1-Centricity Universal Viewer-00558305, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, 4742-3-Centricity Universal Viewer-02182462, 9796-1-Centricity Universal Viewer-00558571, 100770-1-Centricity Universal Viewer-01804127, 9752-1-Centricity Universal Viewer-02393053, 9752-1-Centricity Universal Viewer-00558454, 13225-1-Centricity Universal Viewer-02032334, 100769-1-Centricity Universal Viewer-01298556, 100769-1-Centricity Universal Viewer-02395799, 2403-7-Centricity Universal Viewer-01973509, 100468-1-Centricity Universal Viewer-02287985, 100468-1-Centricity Universal Viewer-02288300, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, 4683-1-Centricity Universal Viewer-00558456, 4601-1-Centricity Universal Viewer-00558699, 101310-1-Centricity Universal Viewer-02039946, 4347-1-Centricity Universal Viewer-00558520, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, AH4325-Centricity Universal Viewer-00160202, AH5291-Centricity Universal Viewer-00394902, AP6264-Centricity Universal Viewer-00000180, AP6469-Centricity Universal Viewer-01816421, AH0116-Centricity Universal Viewer-00160203, AH0106-Centricity Universal Viewer-00160204, 613493-Centricity Universal Viewer-02175791, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-02097256, 313741-Centricity Universal Viewer-15591262, 000282202-Centricity Universal Viewer-02291736, 571064-Centricity Universal Viewer-01293639, A54852-Centricity Universal Viewer-00043560, M41980-Centricity Universal Viewer-00044515, HC0399-Centricity Universal Viewer-01282972, PC1695-Centricity Universal Viewer-01447701, 786787-Centricity Universal Viewer-01283171, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, 509940-Centricity Universal Viewer-01813036, HC0529-Centricity Universal Viewer-01364776, 683198-Centricity Universal Viewer-02263377, HC0245-Centricity Universal Viewer-00059319, 600791-Centricity Universal Viewer-02099049, 427990-Centricity Universal Viewer-01813160, 485135-Centricity Universal Viewer-01447706, 2336375-Centricity Universal Viewer-01444341, HC1414-Centricity Universal Viewer-01814335, PC1961-Centricity Universal Viewer-00001720, PC0023-Centricity Universal Viewer-01282279, 531344-Centricity Universal Viewer-00000707, CC0154-Centricity Universal Viewer-01813738, 509585-Centricity Universal Viewer-01826272, 601860-Centricity Universal Viewer-01373156, HC0565-Centricity Universal Viewer-00545595, HC4357-Centricity Universal Viewer-02090320, TP0575-Centricity Universal Viewer-01825777, 81111-Centricity Universal Viewer-01286673, A59927-Centricity Universal Viewer-00040382, A61971-Centricity Universal Viewer-01891850, AMS39-Centricity Universal Viewer-00545606, 268034-Centricity Universal Viewer-18862276, 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, PL1190-Centricity Universal Viewer-21245580, PL1961-Centricity Universal Viewer-01981010, PL2624-Centricity Universal Viewer-00038804, PL1005-Centricity Universal Viewer-02336290, 600062-Centricity Universal Viewer-02095166, PL3362-Centricity Universal Viewer-20631670, PL0326-Centricity Universal Viewer-02040892, PL2975-Centricity Universal Viewer-00162605, PL2971-Centricity Universal Viewer-00038808, RU9255-Centricity Universal Viewer-19727239, 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, RU8366-Centricity Universal Viewer-18045776, 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, RU1107-Centricity Universal Viewer-01813331, RU9216-Centricity Universal Viewer-01982768, 600101-Centricity Universal Viewer-01273190, RU1544-Centricity Universal Viewer-02330871, RU2526-Centricity Universal Viewer-02331246, RU5388-Centricity Universal Viewer-01719556, RU0994-Centricity Universal Viewer-02331254, RU3794-Centricity Universal Viewer-19673911, RU9226-Centricity Universal Viewer-19673912, RU6968-Centricity Universal Viewer-02335840, RU8356-Centricity Universal Viewer-01445768, RU9595-Centricity Universal Viewer-01812133, 600105-Centricity Universal Viewer-02331152, RU9697-Centricity Universal Viewer-19673913, 2422939-Centricity Universal Viewer-01509505, RU0120-Centricity Universal Viewer-02335932, RU9546-Centricity Universal Viewer-01812747, RU3998-Centricity Universal Viewer-01553790, RU6164-Centricity Universal Viewer-19720917, SA1339-Centricity Universal Viewer-00116444, SI4014-Centricity Universal Viewer-01889278, 16218680-Centricity Universal Viewer-02266272, ZA2267-Centricity Universal Viewer-02001877, ZA2541-Centricity Universal Viewer-01985829, ZA2472-Centricity Universal Viewer-00116565, 482896-Centricity Universal Viewer-00545574, 941804-Centricity Universal Viewer-02287043, 85021-Centricity Universal Viewer-01426096, 318055-Centricity Universal Viewer-01457316; UDI/DI none, 4413-2-Centricity Universal Viewer-01300927, 4413-2-Centricity Universal Viewer-01300929, 4267-5-Centricity Universal Viewer-20884363, 4267-5-Centricity Universal Viewer-20884364, 4267-5-Centricity Universal Viewer-20884365, 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, 100837-1-Centricity Universal Viewer-00558435, 100837-1-Centricity Universal Viewer-17594527, 13356-2-Centricity Universal Viewer-00558681, 4379-1-Centricity Universal Viewer-02184891, 102335-1-Centricity Universal Viewer-00558675, 13240-2-Centricity Universal Viewer-00558103, 13228-1-Centricity Universal Viewer-00558678, 101274-1-Centricity Universal Viewer-00558679, 101274-1-Centricity Universal Viewer-20279342, 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 13125-1-Centricity Universal Viewer-02268546, 102359-1-Centricity Universal Viewer-00558696, 4441-1-Centricity Universal Viewer-00558677, 4578-1-Centricity Universal Viewer-00558340, 2403-7-Centricity Universal Viewer-00558347, 11042-1-Centricity Universal Viewer-02285888, 11042-1-Centricity Universal Viewer-19603374, 280801-Centricity Universal Viewer-19737221, A91901-Centricity Universal Viewer-00044549, CC4105-Centricity Universal Viewer-01282278, HC4105-Centricity Universal Viewer-00001393, 233637-Centricity Universal Viewer-15773152, A54120-Centricity Universal Viewer-00040449, KW0000-Centricity Universal Viewer-01416913, BON01-Centricity Universal Viewer-00044131, PL3349-Centricity Universal Viewer-00038811, PL3277-Centricity Universal Viewer-00038831, 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, RU1107-Centricity Universal Viewer-01273207, RU3453-Centricity Universal Viewer-01273249, TBD-Centricity Universal Viewer-01273292, MPX352-Centricity Universal Viewer-19629107, DP7603-Centricity Universal Viewer-20093544, FP5028-Centricity Universal Viewer-00110911, 651948-Centricity Universal Viewer-01813739, 124774-Centricity Universal Viewer-00000208, 237870-Centricity Universal Viewer-01444278
Where was it sold?
US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GE Healthcare
All 512| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Signa Premier systems recalled by GE Healthcare | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity Universal Viewer Zero Footprint Client recalled | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled | GE Healthcare | Device Malfunction | |
| Device | CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
| Device | CLASS II | Centricity Centricity Pacs-iw with Universal Viewer recalled | GE Healthcare | Other | IL |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |