LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System…
Medical device recall Z-1051-2016. 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
- 324 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?
LightSpeed 16 (MDAS only , , 2339985 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.
324, 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 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927…
Every code shown here, 1,995 characters
Mfg Lot or Serial # System ID 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927 00001010424YM8 0910212127 00001010461YM0 0910212129 00001010461YM0 0910212129 00001010471YM9 0910213084 00000980093YM9 0910212119 00000980093YM9 0910212119 00000994084YM2 0910212123X 00000984698YM1 0910213080 00001010387YM7 0910215023 00001010475YM0 0910215025 00001001897YM6 AH5703CT01 00000980120YM0 AH4001PE01 00000988410YM7 110002CT02 00000953828YM1 110017CT01 00000980106YM9 110040CT03 00000953853YM9 110059CT01 00000988410YM7 110002CT02 00000980111YM9 030355CT03 00000980111YM9 030355CT03 00001002103YM8 2858149 00000383739CN0 CT383739CN0 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00001002107YM9 082421120191 00000364134CN7 082445160009 00000365398CN7 082445040002 00000363607CN3 082421100316 00001002106YM1 082421110048 00000953856YM2 082421120171 00001001852YM1 082421120187 00001010423YM0 082421100294 00001010444YM6 082421100301 00000941008YM5 082421020154 00000988393YM5 082421030172 00000996079YM0 082421030175 00000988398YM4 082421050047 00000996082YM4 082421100157 00000984688YM2 082421100270 00000988395YM0 082421100276 00000988397YM6 082421100278 00000984685YM8 082421100283 00001010426YM3 082421160169 00001010436YM2 082421160176 00000980095YM4 082421180052 00001010457YM8 082421180061 00001023062YM1 082421180064 00000984699YM9 082421010160 00000941008YM5 082421020154 00000994089YM1 082421100284 00001002104YM6 082421120188 00000984700YM5 082421130071 00000988386YM9 082421130073 00001010451YM1 082421100307 00001010455YM2 082421290042 00001010478YM4 EE1020CT01 00001010478YM4 EE1020CT01 00000953833YM1 FI1052CT02 00000994076YM8 A9885025 00000994074YM3 C2195260 00000994074YM3 C2195260 00000994076YM8 A9885025 00000994086YM7…
FDA’s list runs to 8,145 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 8,145 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.