Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated…
Medical device recall Z-1049-2016. Published in FDA’s Enforcement Report on Mar 16, 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 Mar 16, 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 1 state named
- 817 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 updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
817, 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 00000002631PT0 4860AW442 00000002631PT0 4860AW442 00000318118CN7 0910213115 00000002808PT4 0910453003P 00000318118CN7 0910213115 00000318118CN7 0910213115 00000980093YM9 0910212119 00000002247PT5 090016PT01…
Every code shown here, 1,989 characters
Mfg Lot or Serial # System ID 00000002631PT0 4860AW442 00000002631PT0 4860AW442 00000318118CN7 0910213115 00000002808PT4 0910453003P 00000318118CN7 0910213115 00000318118CN7 0910213115 00000980093YM9 0910212119 00000002247PT5 090016PT01 00000326200CN3 110012CT01 00000311426CN1 030018CT01 00000002103PT0 2728449 00000003306PT8 2757760XXX 00000003306PT8 2757760XXX 00000003310PT0 47867 00000002103PT0 2728449 00000002103PT0 2728449 00000339630CN6 BG4029CT01 00000298328CN6 204787LS1 00000298660CN2 204787LSPD2 00000307018CN2 416249LS16 00000309304CN4 519744LS16 00000309524CN7 819379LS 00000310680CN4 418862LS 00000312264CN5 450656LS 00000316257CN5 613761LS16 00000317195CN6 604988LS16 00000318444CN7 514499LS 00000318927CN1 514468BLS 00000319310CN9 519421LS16 00000324459CN7 450466LS 00000328940CN2 450654LS 00000329994CN8 819561LS 00000332076CN9 506648LS16 00000335314CN1 514934CLS16 00000341799CN5 416284LS16 00000341801CN9 416744LS16 00000341802CN7 905883LS16 00000347191CN9 450778LS 00000348810CN3 416924DST 00000349405CN1 514934BDST 00000994091YM7 418549LS 00000334561CN8 26329CT4X 00000002642PT7 082445310001 00000002660PT9 082445310003 00000340577CN6 082421120176 00000340630CN3 082421140148 00000989604YM4 082421030247 00000989603YM6 082421040128 00000989606YM9 082421080068 00000989606YM9 082421080068 00000989602YM8 082421100277 00000989607YM7 082421210116 00000352887CN4 USONCDST16 00000346880CN8 2532905LIG16 00000295643CN1 FI1017CT02 00000334897CN6 A9190135 00000001843PT2 B4155412 00000334897CN6 A9190135 00000002494PT3 GOLD010013 00000341585CN8 GOLD010316 00000336468CN4 M4143946 00000002494PT3 GOLD010013 00000339849CN2 M4215541 00000339849CN2 M4215541 00000336833CN9 M4434860 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000001843PT2 B4155412 00000293499CN0 M5481223 00000302751CN3 M4516011 00000309305CN1 M4491923 00000310268CN8 M4191025 00000313650CN4 C6010809 00000326112CN0 M1279722 00000329304CN0 X993729001 00000980112YM7 M4490502…
FDA’s list runs to 20,756 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 including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
The states and territories these words name
- Puerto Rico
They leave out North Dakota, Vermont and 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.
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 Feb 10, 2016.
- FDA classified it on Mar 4, 2016.
- FDA’s Enforcement Report published it on Mar 16, 2016.
- FDA terminated it on Sep 21, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, 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 20,756 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
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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.