GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation…
Medical device recall Z-0901-2013. Published in FDA’s Enforcement Report on Mar 13, 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 Mar 13, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 27 states named in where it went
- 363 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?
Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology, surgery, and treatment planning.
363, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS…
Every code shown here, 1,995 characters
000000010009GS 000000010017GS 000000010049GS 000000010045GS 000000010001GS 000000010030GS 000000010004GS 000000010062GS 000000010054GS 000000010028GS 000000010005GS 000000010086GS 000000010002GS 00000L026FFE60 00000L0271A594 000000010081GS 000000010041GS 000000010024GS 000000010026GS 000000010043GS 000000010072GS 000000010079GS 000000010082GS 000000010057GS 000000010051GS 000000010071GS 000000010064GS 000000010073GS 000000010077GS 000000010038GS 000000010053GS 000000010047GS 000000010033GS 000000010094GS 000000010050GS 000000010021GS 000000010015GS 00000L0219C835 000000010059GS 000000010012GS 000000010018GS 000000010060GS 000000010003GS 000000010008GS 000000010014GS 000000010020GS 000000010075GS 000000010074GS 00000L0274A04C 000000010022GS 000000010048GS 000000010067GS 000000010063GS 000000010087GS 000000010034GS 000000010083GS 000000010036GS 000000010080GS 000000010044GS 000000010006GS 000000010068GS 000000010027GS 000000010091GS 000000010032GS 000000010029GS 000000010078GS 000000010007GS 000000010013GS 000000010090GS 000000010065GS 000000010016GS 000000010055GS 000000010069GS 000000010076GS 000000010052GS 000000010025GS 000000010092GS 000000010070GS 000000010089GS 000000010046GS 00000LEE1BC41D 000000010042GS 000000010061GS 000000010066GS 00000L0236B9CE 00000LEE1BC908 00000L023A0E34 00000L02019460 00000L02019ABA 00000L025B5C0C 00000LEE17087C 00000L610029DF 00000LEE1A72F8 00000L02374674 00000L025871B4 00000LEE1AA670 00000L6100BCF6 00000L61009728 00000L02167EAD 00000LEE1AD7CE 00000LEE170AEC 00000L6100B3FF 00000L6100C191 00000L022E0038 00000L0237474C 00000LEE1AD631 00000LEE1BC30A 00000L0235D1DC 00000L6100C520 00000L6100B968 00000L6100BCA9 00000L0265F43C 00000L6100BE7F 00000L0201485E 00000L0236B9CC 00000L0268E922 00000L020730A2 00000L0233B384 00000L025ADA52 00000L6100C4DC 00000L6100974C 00000L6100B69C 00000L0207263E 00000L6100BFE0 00000L0201994E 00000LEE1AD74B 00000L0235B34E 00000L025A17EE 00000LEE1AD7CD 00000L6100C4E1 00000L61009E1D 00000L0201521E 00000LEE170AC1…
FDA’s list runs to 5,047 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 including the states of AR, CA, CO, FL, GA, IL IN, IA, LA, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX and VA. and the countries of ALGERIA, AUSTRALIA, AUSTRIA, ARGENTINA, BELARUS, CANADA, CHINA, CHILE, EGYPT CZECH REPUBLIC, FRANCE, FINLAND, GERMANY, GABON, HONG KONG, INDIA, IRELAND, ITALY KENYA, KOREA, JAPAN, MEXICO, NIGERIA, PHILIPPINES, PORTUGAL REPUBLIC OF MALTA, RUSSIAN FEDERATION SAUDI ARABIA, SPAIN SWITZERLAND, TURKEY, TAIWAN, TUNISIA, UNTIED KINGDOM and VENEZUELA.
The states and territories these words name
27 states and territories.
Every one of them
- Arkansas
- California
- Colorado
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
The words say it went outside the United States too.
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 May 25, 2012.
- FDA classified it on Mar 1, 2013.
- FDA’s Enforcement Report published it on Mar 13, 2013.
- FDA terminated it on Jan 28, 2014.
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 5,047 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.