CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
Centricity Universal Viewer recalled by GE Healthcare
GE Healthcare is recalling Centricity Universal Viewer with Pacs-iw foundation 6.0.x displays medical images, distributed in 13 states. The recall was initiated on 11 Oct 2018 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-0375-2019
- FDA event ID
- 81418
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2018
- FDA classified
- 2 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 11 Oct 2018 | Recall initiated by company | |
| 2 Nov 2018 | Classified by FDA | +22 days |
| 14 Nov 2018 | 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
Synchronization failure
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 with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
Where it was distributed
CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
CaliforniaColoradoDelawareFloridaHawaiiNew YorkOklahomaPennsylvaniaSouth DakotaTexasWashingtonWisconsinWest Virginia
Questions about this recall
Why was it recalled?
Synchronization failure
Which lots are affected?
06051-Centricity Universal Viewer-00115203 06051PAC04; 102278-1-Centricity Universal Viewer-00558682 1-644600677; 102359-1-Centricity Universal Viewer-00558696 1-473998727; 102406-2-Centricity Universal Viewer-00558111 1-661827397; 102406-2-Centricity Universal Viewer-00558686 1-750710672; 102406-2-Centricity Universal Viewer-00558692 1-682147792; 102406-2-Centricity Universal Viewer-00558707 1-802428413; 103090-2-Centricity Universal Viewer-00546048 303715CVUWTSW; 104336-1-Centricity Universal Viewer-00346858 918277CVUWBSW; 13296-1-Centricity Universal Viewer-01364047 LCSH01364047; 1472-15-Centricity Universal Viewer-01367676 210875CAUVSW; 190171-Centricity Universal Viewer-00044015 190171ST05; 2440-1-Centricity Universal Viewer-00558701 PACS-IW-150; 282927-Centricity Universal Viewer-01806769 416813TESTRPACSUV; 300013-Centricity Universal Viewer-00156933 300013ST22; 329052-Centricity Universal Viewer-01443407 HCIT4270016UV; 339734-Centricity PACS-IW-01444878 HCIT4114402PIW;¿ 34381-Centricity Universal Viewer-00116124 34381PAC04; 34381-Centricity Universal Viewer-01980265 Installation tracked via Service Cloud Installed Product ID.; 4271-1-Centricity Universal Viewer-00558351 PACS-IW-129; 4289-1-Centricity Universal Viewer-00558459 PACS-IW-352; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4325-51-Centricity Universal Viewer-00599129 1-592001096; 4406-1-Centricity Universal Viewer-00558683 PACS-IW-323; 4491-1-Centricity Universal Viewer-00558690 PACS-IW-253; 48010-Centricity Universal Viewer-01444602 48010PAC04; 53008-Centricity Universal Viewer-00116118 53008PAC03; 81111-Centricity Universal Viewer-01286673 81111DBS01; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 899010-Centricity Universal Viewer-01300907 Installation tracked via Service Cloud Installed Product ID.; 9752-1-Centricity Universal Viewer-00558454 PACS-IW-288; 9796-1-Centricity Universal Viewer-00558571 1-368083413; A54120-Centricity Universal Viewer-00040449 A5412010; A54852-Centricity Universal Viewer-00043560 A5485262 / A5485266 / A5485267 / A5485269 / A5485270 / A5485271; A91901-Centricity Universal Viewer-00044549 A9190177; A91901-Centricity Universal Viewer-01509889 A9190177; AMS39-Centricity Universal Viewer-00545606 AMS3963; AMS39-Centricity Universal Viewer-00545606 AMS3963; BON01-Centricity Universal Viewer-00044131 BON0164; ECT02-Centricity Universal Viewer-00059842 ECT0265; FP5028-Centricity Universal Viewer-00110911 FP502804; GH1077-Centricity Universal Viewer-01724675 GH1077UV01 Installation tracked via System ID. 4435495-1 Installation tracked via System ID. HCIT4270016UV¿ Installation tracked via System ID. HN-NA¿ Installation tracked via System ID. HCIT4220435UV Installation tracked via System ID. HCIT4264206UW¿; M15393-Centricity Universal Viewer-00043611 M1539319 / M1539321 / M1539322; M232471-Centricity Universal Viewer-00043629 M23247104; M41870-Centricity Universal Viewer-00043721 M4187019 /M4187021 / M4187022; M41913-Centricity Universal Viewer-00065993 M4191318 / M4191319; M41980-Centricity Universal Viewer-00044515 M41980107; M42073-Centricity Universal Viewer-00044530 M4207315; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M42176-Centricity Universal Viewer-00043763 M4217634 / M4217636 / M4217628; M44599-Centricity Universal Viewer-00043784 M4459914 / M4459916 / M4459917; M44875-Centricity Universal Viewer-00043829 M4487535; M44877-Centricity Universal Viewer-00043766 M4217637 / M4487710; M44997-Centricity Universal Viewer-00397920 M44997011; M45006-Centricity Universal Viewer-00043854 M4500623 / M4500625 / M4500626; PL1124-Centricity Universal Viewer-00038795 PL1124RW01; PL2970-Centricity Universal Viewer-00038797 PL2970RW01; PL3249-Centricity Universal Viewer-00038866 PL3249RW02; PL3277-Centricity Universal Viewer-00038831 PL3277RW01; PX4900-Centricity Universal Viewer-01369835 PX4900SV02; SA1339-Centricity Universal Viewer-00116444 Installation tracked via Service Cloud Installed Product ID; X1413856-Centricity Universal Viewer-00044474 X141385617; X1982342-Centricity Universal Viewer-00043950 X198234211 / X198234210; X3141198-Centricity Universal Viewer-00043959 X314119802; YP3150-Centricity Universal Viewer-01639018 Installation tracked via Service Cloud Installed Product ID.; ZA00113-Centricity Universal Viewer-01474463 ZA2990PP02; ZA1058-Centricity Universal Viewer-01724673 ZA1058UV01; and ZA2551-Centricity Universal Viewer-00116834 ZA2551PAC1.
Where was it sold?
CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81418This product is part of a recall event; the main page for the event is Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare | GE Healthcare | Device Malfunction | 13 states |
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