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
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled four models of nuclear medicine imaging systems: the Discovery NM/CT 670, Optima NM/CT 640, Discovery NM 630, and Brivo NM 615. The recall addresses a potential safety hazard in which the detector component may contact a patient's elbow during SPECT (single-photon emission computed tomography) scans used for pulmonary imaging, specifically when using 450 angular step protocols. A total of 464 systems have been affected worldwide, including 143 units in the United States and 321 units internationally across numerous countries.
The recalled systems are identified by specific serial numbers and system IDs that span from 2010 to 2022 manufacturing dates. The recall affects equipment distributed throughout the United States and in countries including Canada, Australia, China, Germany, France, Brazil, and many others. The source document does not specify what actions affected consumers or medical facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: 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 Quantity: 464 (143 US, 321 OUS) Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.