Centricity Universal Viewer with PACS-IW foundation 6.0
Medical device recall Z-1886-2019. Published in FDA’s Enforcement Report on Jul 3, 2019.
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 Jul 3, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 292 units 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?
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product 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.
292 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product ID numbers: 102123-1-Centricity Universal Viewer-00558570 102123-1-Centricity Universal Viewer-02157634 2049-1-Centricity Universal Viewer-00558112 1011-1-Centricity Universal Viewer-00558109 1011-1-Centricity Universal…
Every code shown here, 1,985 characters
Product ID numbers: 102123-1-Centricity Universal Viewer-00558570 102123-1-Centricity Universal Viewer-02157634 2049-1-Centricity Universal Viewer-00558112 1011-1-Centricity Universal Viewer-00558109 1011-1-Centricity Universal Viewer-02097166 1011-1-Centricity Universal Viewer-02097165 4413-2-Centricity Universal Viewer-01300927 4413-2-Centricity Universal Viewer-01300929 101171-1-Centricity Universal Viewer-02288391 104535-4-Centricity Universal Viewer-01806096 104535-4-Centricity Universal Viewer-01806096 4406-1-Centricity Universal Viewer-00558683 4406-1-Centricity Universal Viewer-00558683 4446-2-Centricity Universal Viewer-00558643 4415-1-Centricity Universal Viewer-00558359 4415-1-Centricity Universal Viewer-01973510 4491-1-Centricity Universal Viewer-00558690 100256-1-Centricity Universal Viewer-00558700 100256-1-Centricity Universal Viewer-01810788 104287-2-Centricity Universal Viewer-00555505 4318-1-Centricity Universal Viewer-00558703 4048-1-Centricity Universal Viewer-00558695 4460-1-Centricity Universal Viewer-02255583 4460-1-Centricity Universal Viewer-01819618 4460-7-Centricity Universal Viewer-02255586 101120-1-Centricity Universal Viewer-00558702 102143-1-Centricity Universal Viewer-00558685 4271-1-Centricity Universal Viewer-00558351 4698-1-Centricity Universal Viewer-00558313 4698-1-Centricity Universal Viewer-00558313 100029-1-Centricity Universal Viewer-02256808 100029-1-Centricity Universal Viewer-02256809 100717-1-Centricity Universal Viewer-01293807 100614-1-Centricity Universal Viewer-00558693 13162-8-Centricity Universal Viewer-01452133 101044-1-Centricity Universal Viewer-00558694 101044-1-Centricity Universal Viewer-00558694 102580-1-Centricity Universal Viewer-00558689 100837-1-Centricity Universal Viewer-00558435 104136-1-Centricity Universal Viewer-00558686 104271-1-Centricity Universal Viewer-00558707 103228-1-Centricity Universal Viewer-00558111 4451-1-Centricity Universal Viewer-00558107 101726-1-Centricity Universal…
FDA’s list runs to 12,932 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.
Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 May 17, 2019.
- FDA classified it on Jun 26, 2019.
- FDA’s Enforcement Report published it on Jul 3, 2019.
- FDA terminated it on Nov 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 12,932 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.