Hearth Record

GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680

Medical device recall Z-2870-2018. Published in FDA’s Enforcement Report on Aug 29, 2018.

FDA’s own record, on accessdata.fda.gov

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 Aug 29, 2018. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

4,007 devices total (products 1, 2, 3), in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Model Number, Serial Number (System ID): 5454001-260, CBCGG1600028HM (817261ULTRA); 5454001-240, 00000389996HM0 (83021861077017); 5454001-40, 00000074499YC5 (850210882); 5454001-40, 00000075588YC4 (850210905); 5454001-40, 00000069668YC2…

Every code shown here, 1,987 characters

Model Number, Serial Number (System ID): 5454001-260, CBCGG1600028HM (817261ULTRA); 5454001-240, 00000389996HM0 (83021861077017); 5454001-40, 00000074499YC5 (850210882); 5454001-40, 00000075588YC4 (850210905); 5454001-40, 00000069668YC2 (850210888); 5454001-40, 00000075080YC2 (850210904); 5454001-40, 00000071456YC8 (850210894); 5454001-40, 00000077687YC2 (850210910); 5454001-40, 00000073633YC0 (850210902); 5454001-40, 00000073638YC9 (850210900); 5454001-40, 40GAN1600013YC (850210908); 5454001-240, 00000424383HM8 (HU1113CT01); 5454001-240, 00000391751HM5 (DPN26338); 5454001-240, 00000387390HM8 (UE535A128); 5454001-240, 00000394185HM3 (NEV44709); 5454001-240, 00000394592HM0 (NEV44708); 5454001-240, 00000395002HM9 (NPV79344); 5454001-240, 00000415694HM9 (EP223318); 5454001-240, 00000414003HM4 (CS1346CT01); 5454001-240, 00000411639HM8 (CS1046CT01); 5454001-240, 00000385138HM3 (CS1335CT01); 5454001-240, 00000387391HM6 (H2021CT15); 5454001-240, 00000394590HM4 (H2049CT10); 5454001-240, 00000404914HM4 (H2016CT21); 5454001-240, 00000391756HM4 (H2017CT11); 5454001-240, 00000403534HM1 (HU1015CT03); 5454001-240, 00000411637HM2 (HU1158CT02); 5454001-240, 00000405579HM4 (RO1098CT02); 5454001-240, 00000405574HM5 (RO1303CT01); 5454001-40, 00000066732YC9 (RO1188CT01); 5454001-240, 00000420282HM6 (SK1042CT01); 5454001-240, 00000370111HM7 (MEX70100); 5454001-40, 00000063901YC3 (CS1085CT01); 5454001-40, 00000066209YC8 (RO1115CT03); 5454001-40, 00000061249YC9 (RU8891CT01); 5454001-240, 00000418621HM9 (CS1042CT02); 5454001-240, 00000419606HM9 (HU1012CT03); 5454001-240, 00000418622HM7 (600129CT01); 5454001-240, 00000389555HM4 (RO1042CT02); 5454001-240, 00000389550HM5 (RO1152CT02); 5454001-240, 00000385662HM2 (RO1271CT01); 5454001-40, 00000065926YC8 (RO1257CT01); 5454001-40, 00000067504YC1 (BG4693CT02); 5454001-40, 00000060793YC7 (DPN87723); 5454001-40, 00000068716YC0 (FPG39200); 5454001-41, 00000068076YC9 (82421290094); 5454001-230, 000000461669HM4 (82421160460); 5454001-41,…

FDA’s list runs to 71,627 characters. The first part is shown; the rest is on FDA’s record.

Source:

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) distribution to states of: AK, AL, CA, CO, CT, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, WI, WV, WY; and countries of:: ALGERIA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMEROON, Canada, CHILE, CHINA, COLOMBIA, Cote D’Ivoire, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, French Guiana, GERMANY, GHANA, GREECE, GUADELOUPE, GUATEMALA, HONDURAS, Hong Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, Korea (Republic of), KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MALAYSIA, Mali, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW , ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, Palestine, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, REUNION, ROMANIA, Russia, RWANDA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN.

The states and territories these words name

44 states and territories.

Every one of them
  • Alaska
  • Alabama
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Guam
  • Hawaii
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • North Dakota
  • Nebraska
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Wisconsin
  • West Virginia
  • Wyoming

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Apr 27, 2018.
  • FDA classified it on Aug 17, 2018.
  • FDA’s Enforcement Report published it on Aug 29, 2018.
  • FDA terminated it on Aug 21, 2020.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • GE Healthcare Japan Corporation, of Hino, Japan.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 71,627 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

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An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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