GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7,…
Medical device recall Z-2257-2013. Published in FDA’s Enforcement Report on Sep 25, 2013.
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 Sep 25, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 19 states named
- 179 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 recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. 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.
179, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial # 00000179275GE3 00000136608GE7 00000136609GE5 00000123803GE9 00000206492GE1 00000179274GE6 00000179273GE8 00000179272GE0…
Every code shown here, 1,991 characters
Seno Advantage Workstations with RIS CCOW integration: Patient mismatch while receiving images - FMI 12187 Serial # 00000179275GE3 00000136608GE7 00000136609GE5 00000123803GE9 00000206492GE1 00000179274GE6 00000179273GE8 00000179272GE0 00000177331GE6 00000128528GE7 00000132314GE6 00000106422GE9 00000188371GE9 00000179281GE1 00000179282GE9 00000106426GE0 00000106427GE8 00000250274GE8 00000142837GE4 00000142836GE6 000000010001GS 00000114907GE9 00000158810GE2 00000084251GE8 00000112122GE7 00000123807GE0 000000310001GS 000000010008GS 000000010007GS 00000106420GE3 00000114906GE1 00000250277GE1 00000165231GE2 00000136610GE3 00000114088GE8 00000114089GE6 00000112926GE1 00000206490GE5 00000154938GE5 00000190211HP3 00000174027GE3 00000174026GE5 00000190278HP2 000000010004GS 00000164500GE1 00000158809GE4 00000158410GE1 00000165228GE8 00000165229GE6 00000123804GE7 00000166277GE4 00000114091GE2 00000106425GE2 00000106424GE5 00000179280GE3 00000200442GE2 00000250278GE9 00000126082GE7 00000206491GE3 00000164502GE7 00000164503GE5 000000510001GS 00000253622GE5 00000128529GE5 00000126080GE1 00000195402GE3 00000195403GE1 00000218675GE7 00000218674GE0 00000220618GE3 000000010011GS 00000190212HP1 00000220619GE1 000003510001GS 00000117141GE2 00000142832GE5 00000200440GE6 000003310002GS 00000022062GE9 000003310001GS 00000250290GE4 00000295750GE4 00000295751GE2 00000250276GE3 00000295753GE8 00000295752GE0 00000158812GE8 00000166279GE0 000000610001GS 00000075247GE7 00000106423GE7 00000080399GE9 000000610005GS 00000170113GE2 00000L02687311 000000ANT26269 000000G8087001 000000ANT23044 000000ANT25613 000000C7177002 00000193277GE1 00000149802GE1 00000149801GE3 00000165230GE4 000003510003GS 000000310002GS 000000310003GS 000004410002GS 000000610002GS 00000126078GE5 00000126079GE3 000000210002GS 00000164501GE9 00000117137GE0 00000119932GE2 00000142838GE2 000000Q7274004 000000M9335002 000000Q7274002 000000010005GS 000000N7302006 000000C7177009 000000C7177015 00000050606AW3 000000K7291002…
FDA’s list runs to 2,800 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 : AL AZ, CA, CO, CT, FL, GA, IL, IN, MD,MI, MO, NJ, NY, NC, OK, PA, TX and WI., and the countries of : AUSTRIA, BELGIUM, CANADA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, JAPAN, LEBANON, NORWAY, PORTUGAL, SPAIN, SWEDEN and TAIWAN.
The states and territories these words name
19 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Indiana
- Maryland
- Michigan
- Missouri
- North Carolina
- New Jersey
- New York
- Oklahoma
- Pennsylvania
- Texas
- 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 Sep 20, 2012.
- FDA classified it on Sep 19, 2013.
- FDA’s Enforcement Report published it on Sep 25, 2013.
- FDA terminated it on Jul 7, 2016.
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 2,800 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.