GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce…
Medical device recall Z-1940-2013. Published in FDA’s Enforcement Report on Aug 21, 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 Aug 21, 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 29 states named
- 244 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 conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.
244, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3 00000410002CN0 00000408483CN6 00000406075CN2 00000404225CN5 00000405725CN3 00000408128CN7 00000409481CN9 00000408280CN6…
Every code shown here, 1,991 characters
GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3 00000410002CN0 00000408483CN6 00000406075CN2 00000404225CN5 00000405725CN3 00000408128CN7 00000409481CN9 00000408280CN6 00000419816CN4 00000408127CN9 00000408230CN1 00000409450CN4 00000412501CN9 00000411125CN8 00000409344CN9 00000409145CN0 00000412398CN0 00000409881CN0 00000413835CN0 00000413765CN9 00000411126CN6 00000412015CN0 00000412399CN8 00000411349CN4 00000411611CN7 00000414853CN2 00000415105CN6 00000416839CN9 00000416410CN9 00000409806CN7 00000414686CN6 00000420612CN4 00000421374CN0 00000411613CN3 00000415502CN4 00000412042CN4 00000414971CN2 00000413841CN8 00000413362CN5 00000413566CN1 00000420173CN7 00000412503CN5 00000415396CN1 00000415826CN7 00000421147CN0 00000414851CN6 00000415104CN9 00000419891CN7 00000420174CN5 00000414852CN4 00000414973CN8 00000416765CN6 00000418112CN9 00000418335CN6 00000420610CN8 00000416669CN0 00000415439CN9 00000416628CN6 00000417737CN4 00000415469CN6 00000417465CN2 00000419582CN2 00000421590CN1 00000418155CN8 00000417172CN4 00000418484CN2 00000419819CN8 00000418156CN6 00000421378CN1 00000419107CN8 00000422266CN7 00000421121CN5 00000419817CN2 00000422267CN5 00000411391CN6 00000416872CN0 00000417476CN9 00000419135CN9 00000419447CN8 00000408673CN2 00000411348CN6 00000409754CN9 00000409805CN9 00000412738CN7 00000416033CN9 00000416779CN7 00000416974CN4 00000417373CN8 00000409751CN5 00000409343CN1 00000409755CN6 00000409807CN5 00000409753CN1 00000417769CN7 00000414972CN0 00000415092CN6 00000414879CN7 00000416546CN0 00000416122CN0 00000416037CN0 00000419954CN3 00000418659CN9 00000416943CN9 00000417766CN3 00000409879CN4 00000415358CN1 00000413323CN7 00000415204CN7 00000415203CN9 00000417806CN7 00000415448CN0 00000415240CN1 00000414058CN8 00000417618CN6 00000416588CN2 00000416366CN3 00000416545CN2 00000417422CN3 00000418021CN2 00000418154CN1 00000418033CN7 00000421065CN4 00000419773CN7 00000419732CN3 00000417222CN7…
FDA’s list runs to 3,730 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, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUKEY, and UNITED KINGDOM.
The states and territories these words name
29 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kentucky
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- Nevada
- New York
- Pennsylvania
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
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 Apr 5, 2011.
- FDA classified it on Aug 9, 2013.
- FDA’s Enforcement Report published it on Aug 21, 2013.
- FDA terminated it on Aug 11, 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: Visit.
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 3,730 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.