GE Healthcare, AW Server
Medical device recall Z-1137-2013. Published in FDA’s Enforcement Report on Apr 24, 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 Apr 24, 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
- 429 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 with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, AW Server. Product Usage: . 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.
429, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00000248244GE6 000001010056GS 00000256021GE7 00000240706GE2 00000223235GE3 00000218205GE3 00000216337GE6 00000266111GE4…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00000248244GE6 000001010056GS 00000256021GE7 00000240706GE2 00000223235GE3 00000218205GE3 00000216337GE6 00000266111GE4 00000223234GE6 00000276603GE8 00000275004GE0 00000183573HP5 00000183555HP2 00000235884GE4 00000240705GE4 00000222533GE2 00000218207GE9 00000257708GE8 00000275003GE2 00000261642GE3 00000214206GE5 00000214821GE1 00000266112GE2 00000217429GE0 00000240703GE9 00000257707GE0 00000219371GE2 00000235886GE9 00000217427GE4 00000216338GE4 00000183518HP0 00000271798GE1 00000214817GE9 00000216334GE3 00000235885GE1 00000183570HP1 00000216331GE9 00000183568HP5 00000267105GE5 00000217428GE2 00000211978GE2 000001010012GS 00000240704GE7 00000229339GE7 00000216340GE0 00000266110GE6 00000267106GE3 00000260456GE9 00000222536GE5 00000261644GE9 00000214818GE7 00000183562HP8 00000229342GE1 00000276070GE0 00000235883GE6 00000257711GE2 00000257706GE2 00000222535GE7 00000260457GE7 00000246497GE2 00000246500GE3 00000211977GE4 00000261646GE4 00000183557HP8 00000183561HP0 00000213558GE0 00000183558HP6 00000183567HP7 00000223243GE7 00000223240GE3 00000240707GE0 00000216336GE8 00000276602GE0 00000218090GE9 00000L03F0BD38 00000211975GE8 00000276600GE4 00000222534GE0 00000229343GE9 00000219372GE0 00000209172GE6 00000214205GE7 00000261648GE0 00000217426GE6 00000248243GE8 00000223236GE1 00000240708GE8 00000256014GE2 00000213559GE8 00000229341GE3 00000183563HP6 00000183565HP1 00000F11206004 00000B12048002 00000E11026006 0000AB11054001 0000AA11157008 00000E11301005 00000LFB4BA808 00000M11284003 0000AX11314002 00000P10347012 000001010007GS 00000A12038004 0000AX11314001 000001010009GS 000001010008GS 000001010052GS 00000L11074001 00000260454GE4 00000183571HP9 00000218206GE1 00000229344GE7 00000248248GE7 00000267107GE1 00000261643GE1 00000261650GE6 00000257705GE4 00000223239GE5 00000183515HP6 00000183574HP3 00000246496GE4 00000248245GE3 00000261649GE8 00000257710GE4 00000248246GE1…
FDA’s list runs to 6,450 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: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES.
The states and territories these words name
33 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Louisiana
- Maryland
- Michigan
- Missouri
- Montana
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- 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 Jun 28, 2012.
- FDA classified it on Apr 17, 2013.
- FDA’s Enforcement Report published it on Apr 24, 2013.
- FDA terminated it on Feb 4, 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 6,450 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.