Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system
Medical device recall Z-0186-2015. Published in FDA’s Enforcement Report on Nov 19, 2014.
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 Nov 19, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 255 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 is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
255, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3…
Every code shown here, 1,997 characters
21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3 83091096402 21215 100039NU02 21229 210002NU11 21220 BY4033NM01 21166 82426070031 21213 82426040052 21222 082426040053 21231 082426070034 21230 082426080022 21226 TP0007NU02 21155 IE1018MN03 092302HL9 KW1001NM01 092303HL7 KW1112NM04 092307HL8 KW1112NM03 21148 ZWL0630 00000093649HL2 QA1064NM01 21173 RU2581NM01 21190 RU7174NM01 00000290644HM4 RU1493NM01 00000322039HM9 SA1006NM01 095718HL3 SA2315NM01 21219 0847260029 21218 M001NU43 21177 475260NU01 21234 00242NUC06 SAN00200 00258NUC02 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21114 614NCH670 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21188 415353D670 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 SAN00215 615893MMCT1 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 00000000096BH8 0910265076 21001 010120NU19 21008 110022NU05 21034 030133NU13 21050 210060NU02 21056 110017NU06 21104 030082NU13 21132 100032NU05 21162 190163NU04 21167 190163NU06 21178 080041NU04 21179 030360NU01 21214 030037NU08 210088 190052NU09 21164 BG4009NM01 21042 204726D670NM 21048 514848D670 21058 AM1-122ANKH9 21061 514281D670 21077 514842AD670 21085 905883D670 21094 519973D670 21115 613548D670 21122 418549D670A 21123 418549D670B 21135 905684D670A 21137 514338D670 21139 905684D670B 21143 250370D670 21156 905472D670 21184 403943D670 21194 403943D670B 21198…
FDA’s list runs to 4,524 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 Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.
The states and territories these words name
- District of Columbia
- Guam
- Puerto Rico
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 Oct 14, 2014.
- FDA classified it on Nov 7, 2014.
- FDA’s Enforcement Report published it on Nov 19, 2014.
- FDA terminated it on Feb 27, 2015.
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 4,524 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.