GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD
Medical device recall Z-1188-2013. Published in FDA’s Enforcement Report on May 8, 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 May 8, 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
- 166 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?
Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
166, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7…
Every code shown here, 1,994 characters
Serial Number 00000416307CN7 00000416534CN6 00000418451CN1 00000416467CN9 00000414273CN3 00000416594CN0 00000416589CN0 00000416532CN0 00000417617CN8 00000416889CN4 00000416685CN6 00000418151CN7 00000416332CN5 00000416591CN6 00000416468CN7 00000416333CN3 00000419445CN2 00000416269CN9 00000416815CN9 00000416117CN0 00000416524CN7 00000416267CN3 00000419240CN7 00000416646CN8 00000417864CN6 00000416195CN6 00000419505CN3 00000418001CN4 00000416816CN7 00000416551CN0 00000416201CN2 00000417625CN1 00000417650CN9 00000416220CN2 00000419411CN4 00000416390CN3 00000418913CN0 00000416737CN5 00000416738CN3 00000416777CN1 00000416363CN0 00000416888CN6 00000416590CN8 00000417177CN3 00000419041CN9 00000416850CN6 00000416627CN8 00000417275CN5 00000417709CN3 00000417133CN6 00000419446CN0 00000419375CN1 00000418807CN4 00000418035CN2 00000418238CN2 00000418843CN9 00000417786CN1 00000419393CN4 00000417695CN4 00000419507CN9 00000419078CN1 00000419280CN3 00000419390CN0 00000419526CN9 00000419525CN1 00000419559CN0 00000418819CN9 00000419506CN1 00000418402CN4 00000419089CN8 00000419550CN9 00000416736CN7 00000418656CN5 00000416781CN3 00000416798CN7 00000418357CN0 00000419447CN8 00000416552CN8 00000418810CN8 00000416764CN9 00000419178CN9 00000417719CN2 00000416389CN5 00000418514CN6 00000417634CN3 00000416848CN0 00000417733CN3 00000417716CN8 00000416849CN8 00000417649CN1 00000416286CN3 00000416401CN8 00000418847CN0 00000419177CN1 00000416533CN8 00000417644CN2 00000419376CN9 00000419504CN6 00000416231CN9 00000416301CN0 00000417626CN9 00000418403CN2 00000419079CN9 00000416268CN1 00000416620CN3 00000416597CN3 00000416763CN1 00000418780CN3 00000417643CN4 00000416647CN6 00000417642CN6 00000418791CN0 00000416466CN1 00000416388CN7 00000416353CN1 00000417134CN4 00000419241CN5 00000418915CN5 00000419174CN8 00000418818CN1 00000416295CN4 00000417720CN0 00000418846CN2 00000416372CN1 00000416762CN3 00000417714CN3 00000416882CN9 00000417713CN5 00000417725CN9 00000416595CN7 00000418020CN4 00000417734CN1…
FDA’s list runs to 2,503 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 DC and the states of AZ, CA, CO, CT, FL,GA, IL, IN, KY, MA, MI, MS,MO, NH, NJ, NM, NY, NC, OK, OR, PA, SC, SD, TX, UT, VA, WA, and WI and the countries of ALBANIA ARGENTINA AUSTRALIA BELGIUM BRAZIL CANADA CHINA COLOMBIA COSTA RICA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GREECE HONG KONG HUNGARY INDIA IRELAND ITALY JAPAN KOREA, REPUBLIC OF MEXICO MOROCCO NIGERIA NORWAY POLAND RUSSIAN FEDERATION SINGAPORE SPAIN SWEDEN SWITZERLAND TURKEY UKRAINE UNITED KINGDOM.
The states and territories these words name
29 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Illinois
- Indiana
- Kentucky
- Massachusetts
- Michigan
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Jersey
- New Mexico
- New York
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- 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 Jul 25, 2011.
- FDA classified it on Apr 29, 2013.
- FDA’s Enforcement Report published it on May 8, 2013.
- FDA terminated it on Feb 4, 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 2,503 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.