GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version…
Medical device recall Z-2203-2012. Published in FDA’s Enforcement Report on Aug 22, 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 Aug 22, 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 42 states named
- 1055 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 is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. A second issue was also discovered internally. When loading PET data into the Volume Viewer, if slices are missing in a PET serie
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 Product Usage: Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.
1055, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
FMI 25404 Additional Consignees Mfg Lot or Serial # System ID (As required) 00000020D6C6F IE1085AW02 00000029FDB24 A4194418 0000002A8C1D3 ws132201 0000002AB15AF PL1008AW03 00000L0201354A RJ0005 00000L02013776 HC9074AW01 00000L02013900…
Every code shown here, 1,987 characters
FMI 25404 Additional Consignees Mfg Lot or Serial # System ID (As required) 00000020D6C6F IE1085AW02 00000029FDB24 A4194418 0000002A8C1D3 ws132201 0000002AB15AF PL1008AW03 00000L0201354A RJ0005 00000L02013776 HC9074AW01 00000L02013900 00137ADW03 00000L020140F4 10146ADW01 00000L02014128 PPR83607 00000L02014228 082421060040AW 00000L0201485E 813642AW42 00000L0201492C 864366AAW 00000L020149E4 083055065231713 00000L02014C1C 2526577 00000L0201521E 26329AW2 00000L02019460 617355AW3 00000L020194E0 919660AWMRI 00000L020195D0 352CDCAW43 00000L02019690 809780AW2 00000L02019696 510295ANAW 00000L020197FE 2535997AW42 00000L020198A8 WS98556 00000L02019944 706774AW2 00000L02019946 716887AW2 00000L0201994E 716887AW1 00000L02019A02 EG1277AW01 00000L02019ABA 617355AWPC1 00000L02019AE8 850475PAW 00000L0202AC34 082416310006AW 00000L0202AEB4 600160AW01 00000L0202AECA 083055822100526 00000L0202B4AA CC4400AW03 00000L0202B4B8 083049062634502 00000L0202B4BF 083049802101529 00000L0202B4C2 0920559053AW1 00000L0202B4D2 B5298307 00000L0202B52F TN1270AW01 00000L0202B53F TN1273AW01 00000L0202B5BA 900010AW20 00000L0202B639 00860ADW04 00000L0202B668 082421190132AW 00000L0202B677 0910553081AW1 00000L0202B678 082421100352AW 00000L0202B6AE A5251313 00000L0202B773 DPB15840 00000L0202B774 082416040018AW 00000L0202B786 EE672841 00000L0202B7D6 X185801202 00000L0202B7D9 RU1106AW04 00000L0202B7EC 083049202100256 00000L0202B7EE 0853550270 00000L0202B82F RU1834AW01 00000L0202B834 0850270206AW1 00000L0202B84F 00010DCS01 00000L02065AA0 WS98553 00000L02065C50 200ADW42 00000L02068382 470240AW01 00000L0206A4C6 517353MAMAW 00000L0206AC90 850494WSPAW 00000L0207263E 361595SKW1 00000L02072650 419251CTA 00000L020727D2 786AW1BAY 00000L02072ADE RADNETWS1007 00000L02072B8A WCATHWS41 00000L02072B96 973972AWW3 00000L02072B98 515424PC1 00000L02072D02 58831121222 00000L02072D58 916454AW42 00000L02072E4E 3454AWW 00000L020730A2 973972AWW4 00000L020730C8 317621ICAW43 00000L02078D4B 724230AW1 00000L020B0B01 847360AW2…
FDA’s list runs to 28,013 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) including the states of : AL, AZ, AR, CA, CO, DE, DC, FL, GA, GU, HI, IK, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO,MT, NE,NH,NJ, NM, NY, NC, ND, OH, OK, PA, PR, SC, SD, TN, TX, VA, WA, WV, WI and the countries of YUGOSLAVIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SA¿DE ARABIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF MALTA, PORTUGAL, POLAND, PHILIPPINES, NORWAY, NIGERIA, NEW ZEALAND, MEXICO, KOREA, KENYA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, HUNGRY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
The states and territories these words name
42 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
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 Aug 13, 2012.
- FDA’s Enforcement Report published it on Aug 22, 2012.
- FDA terminated it on Dec 11, 2012.
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 28,013 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.