GE Healthcare, Revolution CT Scanners
Medical device recall Z-0401-2016. Published in FDA’s Enforcement Report on Dec 16, 2015.
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 Dec 16, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 17 states named
- 125 (US = 37; OUS = 88) 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 issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
125 (US = 37; OUS = 88), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2…
Every code shown here, 2,000 characters
Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2 220078CT04 00000441574CN1 030355CT07 00000441779CN6 CT441683CN0 00000443105CN2 CT443038CN5 00000440186CN5 E416249CT1 00000437461CN7 519646REVO1 00000442492CN5 E416249CT2 00000443398CN3 905521RCT1 441961CN0 E416249CTE 442082CN4 403944RCT1 442220CN0 604988RCT1 442268CN9 416864RCT1 442573CN2 604682RCT1 AM13ECY81 00000440839CN9 82421040350 00000441053CN6 82421040345 00000441107CN0 82421050106 00000441563CN4 82421040359 00000441930CN5 82421040346 00000442030CN3 82421120479 00000442196CN2 82421030199 00000442749CN8 82421040369 00000443203CN5 82421300072 00000443282CN9 82421190317 00000443322CN3 82421120484 00000443348CN8 82421040370 442794CN4 GON-1510879 00000442517CN9 DK1051CT04 00000437837CN8 M2322254 00000440172CN5 P4192906 00000441238CN3 X41944012 00000441687CN1 M2800929 00000441895CN0 M41980112 00000442351CN3 E4191734 00000442588CN0 M44827197 00000442845CN4 M5480791 00000439243CN7 PC3383CT01 00000441264CN9 HC5284CT04 00000438342CN8 828210096 00000440967CN8 835210259 00000442981CN7 5973CT0019 00000439938CN2 A5624142 00000437028CN4 REV001 00000439356CN7 REV006 00000439639CN6 REV003 00000439802CN0 REV002 00000439812CN9 REV004 00000440092CN5 REV008 00000440113CN9 REV005 00000440682CN3 REV007 00000441280CN5 REV009 00000441460CN3 REV011 00000442008CN9 REV012 00000442404CN0 REV020 00000443513CN7 REV014 00000443527CN7 REV013 00000442704CN3 850210885 00000442992CN4 850210884 00000441573CN3 KW1098CT01 00000442961CN9 GON-4291498 00000442923CN9 NO1146CT02 00000442774CN6 GON-1505695 00000439901CN0 PL1008CT04 00000440335CN8 PL1150CT03 00000440624CN5 SA1012CT10 00000443519CN4 GON-4326652 00000439695CN8 D007CT07 00000440805CN0 A010CT16 00000441378CN7 A010CT17 00000443442CN9 GON-1505146 00000443455CN1 GON-4289981 00000443526CN9 GON-4289991 00000438864CN1…
FDA’s list runs to 3,085 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, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
The states and territories these words name
17 states and territories.
Every one of them
- Alabama
- California
- Connecticut
- Florida
- Georgia
- Hawaii
- Illinois
- North Carolina
- New York
- Ohio
- Oregon
- Pennsylvania
- 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 Oct 23, 2015.
- FDA classified it on Dec 10, 2015.
- FDA’s Enforcement Report published it on Dec 16, 2015.
- FDA terminated it on May 9, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, 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 3,085 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.