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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81418

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 11, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.

Z-0374-2019
Recall number
Z-0374-2019
Initiated
October 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
13

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Synchronization failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Synchronization failure

Code information

102062-1-Centricity Universal Viewer-00558650/1-357058918; 102406-2-Centricity Universal Viewer-00558667/1-640193933; 102406-2-Centricity Universal Viewer-00558669/1-598891571; 102747-1-Centricity Universal Viewer-00558673 /1-626086029; 103246-1-Centricity Universal Viewer-00558668 / 1-681512983; 11580-1-Centricity Universal Viewer-00558646 / 1-417869653; 2403-7-Centricity Universal Viewer-00558347 1-283597082; 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW; 4284-1-Centricity Universal Viewer-00558672 / 1-308060186; 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435; Installation tracked via System ID. / HCIT4216808PIW; Installation tracked via System ID. / 2UA443117XAW; and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.

Distribution pattern

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.

device · product 2 of 2

Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.

Z-0375-2019
Recall number
Z-0375-2019
Initiated
October 11, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
73

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Synchronization failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Synchronization failure

Code information

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.

Distribution pattern

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.