GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
Medical device recall Z-1915-2016. Published in FDA’s Enforcement Report on Jun 15, 2016.
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 Jun 15, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 20 states named
- 197 (US = 68; OUS = 129) 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?
GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE 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.
197 (US = 68; OUS = 129), 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 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A…
Every code shown here, 1,994 characters
Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A 00000442124CN4 N/A 00000442219CN2 N/A 00000442443CN8 N/A 00000443993CN1 N/A 00000444530CN0 N/A 00000445085CN4 N/A 00000438756CN9 309655REVCT 00000439113CN2 212241REVCT 00000439205CN6 415476MCT3 00000439287CN4 415476MCT2 00000439836CN8 215662CTREV 00000440713CN6 815226RVCT 00000441459CN5 206320REV 00000441716CN8 808522RCT 00000442228CN3 281274REV 00000442994CN0 919684REVCT 00000443379CN3 608263REVCT 00000443664CN8 409772CT7 00000443900CN6 402481BEREVCT 00000444165CN5 AM14CFI65 00000444175CN4 801507REV 00000444253CN9 704384REV 00000444745CN4 808KMCCT 00000444872CN6 316268REVCT 00000445059CN9 310222REVO 438369CN1 206598REV1 438902CN9 801662REV1 439823CN6 408356RV1 439835CN0 503216SREV 441040cn3 215952CTREV 441064CN3 256HHRCT1 441066CN8 414805REVCT 441262CN3 RMHCTREV 441990CN9 206598ERREV 442592CN2 205699CTREV 442706CN8 727398REVO 443069CN0 404616CTR 443227CN4 940898REVO 443327CN2 858824REVCT 444398CN2 731541REVCT 444409CN7 386REVCT3 444840CN3 760940REVCT 444913CN8 206288SCREV 00000437624CN0 786596WKRIVO 00000439777CN4 703698REVOCT 00000439930CN9 715847RCT1 00000442124CN4 408498RV2 443327CN2 858824REVCT 00000441624CN4 217876REVO1 00000445085CN4 713792ACT35 00000441575CN8 847437ACT7 442032CN9 512DELLCT 00000442994CN0 N/A 3993CN1 972566OPREVO 445084CN7 708216CTREV 442592CN2 AM13KPM21 444165CN5 317338STVREVO 444970CN8 630527REVO 00000436942CN7 83119511730 00000439799CN8 83119074723 00000441381CN1 83130644883 00000441694CN7 83132979115 00000442968CN4 83141966438 00000439505CN9 190059CT06 00000440315CN0 220078CT04 00000441578CN2 030355CT07 00000441683CN0 CT441683CN0 00000443038CN5 CT443038CN5 00000445060CN7 204787RCT1 00000437410CN4 519646REVO1 440051CN1 E416249CT1 441839CN8 E416249CTE 442044CN4 403944RCT1 442094CN9 604988RCT1 442163CN2…
FDA’s list runs to 4,727 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, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico, New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
The states and territories these words name
20 states and territories.
Every one of them
- Alabama
- California
- Connecticut
- Florida
- Georgia
- Hawaii
- Illinois
- Indiana
- Kansas
- North Carolina
- Nebraska
- New York
- Ohio
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Utah
- 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 May 9, 2016.
- FDA classified it on Jun 6, 2016.
- FDA’s Enforcement Report published it on Jun 15, 2016.
- FDA terminated it on Sep 4, 2018.
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 4,727 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.