GE, Optima CT660
Medical device recall Z-0023-2014. Published in FDA’s Enforcement Report on Oct 23, 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 Oct 23, 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 22 states named
- 380 (52 US & 328 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 related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
380 (52 US & 328 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 # 00000426724CN1 00000429656CN2 00000429809CN7 00000430378CN0 00000430460CN6 00000430480CN4 00000430489CN5 00000430646CN0 00000430650CN2 00000430651CN0 00000430737CN7 00000430795CN5 00000430813CN6 00000430951CN4…
Every code shown here, 2,000 characters
Mfg Lot or Serial # 00000426724CN1 00000429656CN2 00000429809CN7 00000430378CN0 00000430460CN6 00000430480CN4 00000430489CN5 00000430646CN0 00000430650CN2 00000430651CN0 00000430737CN7 00000430795CN5 00000430813CN6 00000430951CN4 00000431016CN5 00000431035CN5 00000431141CN1 00000431269CN0 00000431307CN8 00000431350CN8 00000431506CN5 00000425485CN0 00000424498CN4 00000427441CN1 00000428100CN2 00000429970CN7 00000430427CN5 00000431140CN3 00000431442CN3 00000425128CN6 00000425032CN0 00000428566CN4 00000431662CN6 00000431604CN8 00000431721CN0 00000431708CN7 00000428762CN9 00000428780CN1 00000429600CN0 00000429658CN8 00000429818CN8 00000429877CN4 00000430132CN1 00000430186CN7 00000430264CN2 00000430282CN4 00000430296CN4 00000043742YC6 00000043902YC6 00000045606YC1 00000046476YC8 00000429917CN8 00000037723YC4 00000043482YC9 00000046473YC5 00000042457YC2 00000326336HM5 00000026193YC3 00000328747HM1 00000304641HM4 00000304751HM1 00000305380HM8 00000305871HM6 00000308319HM3 00000310013HM8 00000313520HM9 00000320004HM5 00000322646HM1 00000297489HM7 00000302022HM9 00000318966HM9 00000322993HM7 00000040368YC3 00000327365HM3 00000040081YC2 00000041147YC0 00000042968YC8 00000044150YC1 00000044861YC3 00000045907YC3 00000047740YC6 00000044399YC4 00000045314YC2 00000328079HM9 00000325768HM0 00000027396YC1 00000033407YC8 00000325766HM4 00000299338HM4 00000295308HM1 00000030752YC0 00000312781HM8 00000319291HM1 00000319292HM9 00000322992HM9 00000325769HM8 00000310566HM5 00000311079HM8 00000042014YC1 00000048323YC0 00000048013YC7 00000048014YC5 00000048315YC6 00000048317YC2 00000039804YC0 00000040083YC8 00000041145YC4 00000041828YC5 00000042806YC0 00000042965YC4 00000043220YC3 00000043904YC2 00000044524YC7 00000044858YC9 00000045315YC9 00000045317YC5 00000045603YC8 00000043483YC7 00000044862YC1 00000045316YC7 00000045607YC9 00000045909YC9 00000046475YC0 00000046726YC6 00000046727YC4 00000047521YC0 00000296966HM5 00000038151YC7 00000311081HM4 00000311879HM1 00000328746HM3 00000310567HM3…
FDA’s list runs to 5,704 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 AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
The states and territories these words name
22 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Illinois
- Louisiana
- Massachusetts
- Missouri
- New Hampshire
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- 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 Mar 26, 2013.
- FDA classified it on Oct 17, 2013.
- FDA’s Enforcement Report published it on Oct 23, 2013.
- FDA terminated it on Dec 5, 2013.
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 5,704 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.