GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615
Medical device recall Z-0367-2014. Published in FDA’s Enforcement Report on Nov 27, 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 Nov 27, 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 41 states named
- 464 (143 US, 321 OUS) 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 recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient’s elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 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. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used for patients of all ages. The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of 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. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. - The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scann
464 (143 US, 321 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # System ID 21000 262574D670 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21054 262574D630 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670…
Every code shown here, 1,993 characters
Serial # System ID 21000 262574D670 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21054 262574D630 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21111 DUKECCDSV670NM 21114 614NCH670 21117 262574O640 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21182 GON1409671 21188 415353D670 21189 DUKEDMP670NM 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 21223 307362D670 21224 660890D670 22002 619474D630 22004 618443DISC1 22007 814623D630 22010 251639D630 22012 704355D630 22013 956523D630 22017 845454D630 22018 618842DISC1 22024 601354D630 22025 773282D630 22026 813558D630 22027 941LWRNM630 22029 PRINCE630 22030 281540D630 22032 417781D630 22033 601288D630 22034 913345D630 22036 318798D630 22039 614NCH630 22040 904321DSC1 22041 317887D630 22042 318448D630 22043 JHDSV630NM 22045 217544PH630 22046 301877D630 22047 601798D630 22048 716372NM630 22049 580531NM630 22050 651DSC630 22052 205333D630 22053 618942NM630 22054 813615D630 22055 719587D630 22056 903GSD630 22057 417533D630 22058 708684D630 22059 937SNHC630 22060 GON1399460 22061 GON1399458 22062 GON1399459 22063 GON2996508 22064 918502DIS1 22065 804675D630A 22066 469814NM630 22067 978354DSV630 22068 585922NM630 22069 305596D630A 22070 GON4029581 22072 POIN630 22076 GON1406902 22077 816234D630 22081 808485NM630 22082 989227D630 22085 305596D630B 22087 801714D630 22088 815564D630 22090 GON1413295 22091 702388VNM2 22092 760778D630 22094 269945D630 22095 843347D630 22096 201418D630 22097 319364D630B 22098 207664NM630 22099 334287NM630 22101 609978D630 22103 843797TD630 22105 319364D630A 22112 OSC630 22117 330386D630 22119 909599D630 22122 904276DSC1 22123 270417D630 22124 901226D630 22125 208455NM630 22126 409212NM630 22127 770751D630 22131 DMP630A 22132 936NMD630 22134 856355D630 22135 DMP630B 22136 605322D630 22137 775STMANM630A 22138 951303D630 22139 850862D630 22141 765447D630 22143…
FDA’s list runs to 8,064 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 the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY,. JAPAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, NETHERLANDS, NEW ZEAL NAD, NORWAY, PAKISTAN, POLAND,QUATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN,K THAILAND, TURKEY and UNITED KINGDOM.
The states and territories these words name
41 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- 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 Oct 25, 2013.
- FDA classified it on Nov 20, 2013.
- FDA’s Enforcement Report published it on Nov 27, 2013.
- FDA terminated it on Apr 1, 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: 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 8,064 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.