AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW…
Medical device recall Z-0270-2014. Published in FDA’s Enforcement Report on Nov 20, 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 Nov 20, 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 33 states named
- 1458 (336 US, 1122 OUS) 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 of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
1458 (336 US, 1122 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # 00000270627GE3 00000334603GE8 00000323252GE7 00000315108GE1 00000291160GE0 00000218194GE9 00000334300GE1 00000253041GE8 00000256043GE1 00000L3A331FA4 00000289595GE1 00000323665GE0 00000323664GE3 00000275711GE0…
Every code shown here, 2,000 characters
Mfg Lot or Serial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…
FDA’s list runs to 21,889 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 states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .
The states and territories these words name
33 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- 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 19, 2013.
- FDA classified it on Nov 13, 2013.
- FDA’s Enforcement Report published it on Nov 20, 2013.
- FDA terminated it on Jul 31, 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 21,889 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.