Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and…
Medical device recall Z-0375-2019. Published in FDA’s Enforcement Report on Nov 14, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 13 states named in where it went
- 73 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Synchronization failure
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
73, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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;…
Every code shown here, 1,987 characters
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;…
FDA’s list runs to 4,526 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
13 states and territories.
Every one of them
- California
- Colorado
- Delaware
- Florida
- Hawaii
- New York
- Oklahoma
- Pennsylvania
- South Dakota
- Texas
- Washington
- Wisconsin
- West Virginia
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 11, 2018.
- FDA classified it on Nov 2, 2018.
- FDA’s Enforcement Report published it on Nov 14, 2018.
- FDA terminated it on Mar 20, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,526 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.