GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno…
Medical device recall Z-0095-2013. Published in FDA’s Enforcement Report on Oct 31, 2012.
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 Oct 31, 2012. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 22 states named
- 188 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?
GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
188, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # SA2 000000410032GS 000000410033GS 000000410027GS 000000410047GS 000000410041GS 000000410051GS 000000410087GS 000000410065GS 000000410031GS 000000410035GS 000000410136GS 000000410064GS 000000410037GS 000000410030GS…
Every code shown here, 1,989 characters
Mfg Lot or Serial # SA2 000000410032GS 000000410033GS 000000410027GS 000000410047GS 000000410041GS 000000410051GS 000000410087GS 000000410065GS 000000410031GS 000000410035GS 000000410136GS 000000410064GS 000000410037GS 000000410030GS 000000410049GS 000000410028GS 000000410113GS 000000410069GS 000000410052GS 000000410056GS 000000410043GS 000000410044GS 000000410048GS 000000410038GS 000000410042GS 000000410101GS 000000410036GS 000000410039GS 000000410073GS 000000410054GS 000000410134GS 000000410062GS 000000410112GS 000000410045GS 000000410063GS 000000410060GS 000000410034GS 000000410072GS 000000410057GS 000000410061GS 000000410058GS 000000410050GS 000000410071GS 000000410059GS 000000410055GS 000000410070GS 000000410053GS 000000410029GS 000000410067GS 000000410068GS 000000410066GS 000000410133GS 000000410011GS 000000410010GS 000000410009GS 000000410007GS 000000410006GS 000000410008GS 000000410096GS 000000410089GS 000000410090GS 000000410088GS 000000410086GS 000000410001GS 000000410046GS 000000410040GS 000000410014GS 000000410013GS 000000410015GS 000000410012GS 000000410022GS 00000L0265F2Fe 000000410016GS 000000410018GS 00000L02746AAA 000000410005GS 000000410019GS 000000410017GS 000000410023GS 000000410024GS 00000L0215A2F7 000000410020GS 000000410021GS 000000410109GS 000000410104GS 000000410103GS 000000410105GS 000000410106GS 000000410107GS 000000410102GS 000000410119GS 000000410108GS 000000410091GS 000000410098GS 000000410100GS 000000410082GS 000000410135GS 000000410078GS 000000410079GS 000000410085GS 000000410081GS 000000410080GS 000000410093GS 000000410094GS 000000410083GS 000000410084GS 000000410077GS 000000410076GS 000000410075GS 00000L028421B6 000000410124GS 000000410127GS 000000410120GS 000000410125GS 000000410131GS 000000410132GS 000000410123GS 000000410122GS 000000410126GS 000000410121GS 000000410128GS 000000410130GS 000000410129GS 000000410025GS 00000L021564F6 000000410092GS 000000410074GS 000000410117GS 000000410099GS 000000410114GS 000000410026GS…
FDA’s list runs to 2,880 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--USA (nationwide) including the states of CA, CO, CT, DC, FL, GA, KY,LA, MA, MO, NV, NJ, NY, NC, OH, OK, PA, SD, TN, TX, VA and WI., and the countries of UNITED KINGDOM, TUKEY, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL, NEW ZEALAND, NETHERLANDS, MEXICO, MALAYSIA, KOREA, JAPAN, ITALY, HUNGARY, GREECE, GERMANY, FRANCE, CHINA, CANADA, BRAZIL, AUSTRIA and ALGERIA.
The states and territories these words name
22 states and territories.
Every one of them
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Kentucky
- Louisiana
- Massachusetts
- Missouri
- North Carolina
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Dakota
- Tennessee
- Texas
- Virginia
- Wisconsin
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 24, 2012.
- FDA classified it on Oct 19, 2012.
- FDA’s Enforcement Report published it on Oct 31, 2012.
- FDA terminated it on Mar 26, 2013.
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 2,880 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.