{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tirat Carmel",
      "state": "",
      "country": "Israel",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91456",
      "recalling_firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING",
      "address_1": "4, Hayozma St",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.  US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.",
      "recall_number": "Z-1058-2023",
      "product_description": "GE Nuclear Medicine 600/800 series systems, specifically: a)\t850,  b)\t850 / Dismount,  c)\t850 3/8 inch NM Gantry,  d)\t860 / Dismount,  e)\t860 3/8 inch NM Gantry,  f)\t860 5/8 inch NM Gantry,  g)\t860 BJ,  h)\tNM 830 3/8 inch BJ,  i)\tNM/CT 850 3/8 inch BJ,  j)\tNM/CT 850 3/8 inch ROW,  k)\tNM/CT 850 3/8 inch ROW_,  l)\tNM/CT 850 CT 850 3/8 inch,  m)\tNM/CT 850 ES 3/8 inch,  n)\tNM/CT 850 ES 3/8 inch ROW,  o)\tNM/CT 860 3/8 inch,  p)\tNM/CT 860 3/8 inch BJ,  q)\tNM/CT 860 3/8 inch ROW,  r)\tNM/CT 860 ADVANCE,  s)\tNM/CT 860 advance 3/8 inch NM Gantry,  t)\tNM/CT 860 BEYOND,  u)\tNM/CT 860 beyond 3/8 inch NM Gantry,  v)\tNM/CT 860 China for China,  w)\tNM/CT 860 CT 860 3/8 inch,  x)\tNM/CT 860 ES 3/8 inch,  y)\tNM/CT 860 ES 3/8 inch ROW,  z)\tNM/CT 850 3/8 inch,  aa)\tNM/CT 850 ES 3/8 inch ROW,  bb)\tNM/CT 860 3/8 inch CH,  cc)\tXELERIS 4 DR WORKSTATION;    Emission Computed Tomography System",
      "product_quantity": "380 units",
      "reason_for_recall": "A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.",
      "recall_initiation_date": "20221219",
      "center_classification_date": "20230208",
      "report_date": "20230215",
      "code_info": "a) 850: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers:  NT3BG2200006BH;  b) 850 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers:  NT3BG2100003BH;  c) 850 3/8 inch NM Gantry: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers: 85EY67037, 850Z61033, 85EY67039, 85EY67048, 850Y61018, 850Y61009, 85EY67035, 85EX67001, 85EX67020, 85EY67045, 85EX67023, 85EY67032, 85EY67046, 850A61063, 850Z61047, 85EY67047, 850Z61053, 850Y61006, 850Y61010, 850X61005, 850Y61021, 85EZ67062, 85EX67019, 85EX67021, 85EA67063, 850A61069, 85EX67008, 85EY67040, 850Z61051, 850Z61038, 850A61075, 850Y61025, 850Z61030, 85EY67015, 85EX67017, 85EY67043, 850Z61042, 850Z61061, 85EY67026, 850A61065, 85EX67012, 850Y61023, 85EY67041, 850A61062, 850A61076, 850Y61012, 850A61064, 85EZ67058, 85EX67006, 850Z61043, 850Z61055, 85EY67042, 85EZ67055, 85EY67036, 85EX67024, 85EY67038, 85EX67022, 85EY67025, 85EZ67060, 850Z61058, 850Z61044, 850Z61045, 850Y61020, 850Z61032, 85EZ67056, 85EA67065, 85EY67028, 850Z61041, 85EX67002, 85EX67009, 850A61072, 850Z61036, 850A61068, 850A61071, 850Z61060, 850Z61034, 850Z61039, 850Z61035, 850Z61040, 85EY67031, 850Z61056, 850Z61057, 850Y61016, 85EX67016, 85EA67066, 85EX67004, 850Z61029, 850Z61031, 85EX67011, 85EX67010, 850Y61013, 850Y61015, 850Y61017, 850A61070, 85EX67005, 850A61073, 85EX67018, 85EY67033, 850Z61027, 85EX67013, 850Z61054, 850X61001, 85EZ67053, 85EZ67054, 85EZ67057, 850X61004, 850Z61059, 850Z61052, 850Y61014, 850Z61048, 850Y61026, 850Y61019, 85EY67044, 850Z61037, 850X61002, 85EX67003, 85EX67014, 850Y61007, 85EY67049, 85EZ67052, 850A61067, 850A61074, 85EY67050, 85EZ67051, 85EY67027;   UDI/DI (01)00840682140775(21)850B61120(11)220700, Serial Numbers: 850B61120; UDI/DI 010084068214077521850Y6101111190300, Serial Numbers:  850Y61011; UDI/DI  To be provided, Serial Numbers:  850A61083, 85EA67080, 850B61127, 850B61128, 850B61129, 850B61130, 85EB67087, 850B61133, 850B61134, 850B61135, 850B61101, 85EA67070, 850B61119, 850B61102, 850B61115, 85EA67076, CHBB65669, 850B61122, 850B61132, 850B61131, 85EA67075, 85EA67077, 85EB67088, 850A61093, 85EB67086, 850B61126, 850A61089, 85EA67078, 850B61112, 850B61111, 850B61110, 850B61107, 850B61109; Catalog number To be provided, UDI/DI To be provided, Serial Numbers:   60B62111;  d) 860 / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers:  NT3CG2100006BH;  e) 860 3/8 inch NM Gantry: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers:  860Y62009, 860Y62010, 860Z62027, 860Y62005, 860A62049, 860Y62019, 860Y62014, 860Y62025, 860Z62028, 860Y62024, 860Z62038, 860A62063, 860Z62042, 860Y62017, 860A62065, 860A62058, 860Z62046, 860A62057, 860Z62041, 86EA76004, 860B62118, 860Z62043, 860A62060, 860Z62026, 860Y62006, 860Y62015, 860Y62004, 860Z62047, 860Y62020, 860A62050, 860Z62030, 860Y62007, 860X62002, 860Z62032, 860Y62021, 86EA76003, 860Z62040, 860Z62037, 860Z62031, 860A62062; , UDI/DI 010084068214075121860A6207711211000, Serial Numbers:  860A62077; UDI/DI (01)00840682140751(21)860B62097(11)220300, Serial Numbers:  860B62097;  UDI/DI 010084068214075121860B6209611220300, Serial Numbers:  860B62096; UDI/DI 010084068214075121860A6205911210400, Serial Numbers:  860A62059;  UDI/DI 010084068214075121860A6206811210600, Serial Numbers:  860A62068;  UDI/DI 010084068214075121860Y6202311191100, Serial Numbers:  860Y62023;  UDI/DI 010084068214075121860Y6201311190600, Serial Numbers:  860Y62013; UDI/DI To be provided, Serial Numbers:  860A62067, 860Y62016, 860B62117, 860B62100, 860B62105, 860B62090, 860A62072, 860B62108, 860B62110, 860A62078, 860A62083, 860B62094, 860A62066, 860A62084, 860A62071, 860A62070, 860A62073, 860A62069, 860B62095, 860A62086, 860A62081, 860A62085, 860B62099, 860B62115, 860A62082, 860B62114, 860A62074, 860Z62034, 86EB76006, 860B62122, 860B62119, 860B62121, 860B62089, 86EB76007, 860A62076, 860A62079, 860B62116, 86EB76009, 860B62120, 860B62093, 860A62080, 860B62098, 860B62091, 860B62103;  f) 860 5/8 inch NM Gantry: Catalog number H3908AE, UDI/DI To be provided, Serial Numbers:  860X62001; , UDI/DI Not Applicable, Serial Numbers:  860Z62035;  g) 860 BJ: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers:  NT3CG1900007BH, NT3CG1900008BH, NT3CG1900009BH;   h) NM 830 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers:  NT3AG1900007BH, NT3AG2100001BH, NT3AG2100006BH;  i) NM/CT 850 3/8 inch BJ: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers:  NT3BG2000003BH, NT3BG2100001BH, NT3BG2200001BH, NT3BG1900001BH, NT3BG2200002BH, NT3BG2000004BH, NT3BG2100004BH, NT3BG2200005BH; : Catalog number H2407AA, UDI/DI Not Applicable, Serial Numbers:  NT3BG2000001BH; , UDI/DI To be provided, Serial Numbers:  NT3BG2100002BH; : Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers:  NT3BG2000002BH;  j) NM/CT 850 3/8 inch ROW: Catalog number 5376204-50-1, UDI/DI Not Applicable, Serial Numbers:  NT3BG2100005BH, NT3BG1900002BH; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers:  850Y61022, 850Z61046, 850Y61008; UDI/DI To be provided, Serial Numbers: 850B61100;  k) NM/CT 850 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers:  860Y62008;    l) NM/CT 850 CT 850 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850A61092, 850B61108, 850B61096, 850A61080, 850Z61050, 850B61106, 850B61097, 850A61077, 850B61118, 860B62112; Catalog number 5376204-50, UDI/DI 010084068214077521850A6109511211200, Serial Numbers:  850A61095; UDI/DI 010084068214077521850A6108811210900, Serial Numbers:  850A61088; UDI/DI 010084068214077521850B6112111220700, Serial Numbers:  850B61121; UDI/DI 010084068214077521850B6110411220400, Serial Numbers:  850B61104; UDI/DI 010084068214077521850A6108711210900, Serial Numbers:  850A61087; UDI/DI 010084068214077521850A6108211210800, Serial Numbers:  850A61082; UDI/DI 010084068214077521850B6110511220400, Serial Numbers:  850B61105; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers:  850A61081; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers:  850Z61049, 850A61066; UDI/DI To be provided, Serial Numbers:  850B61098, 850B61099, 850A61084, 850B61123, 850B61113, 850B61117, 850B61116, 850A61090, 850A61079, 850A61091, 850B61114, 850A61078, 850A61086; : Catalog number To be provided, UDI/DI To be provided, Serial Numbers:  850B61125, 850B61103;  m) NM/CT 850 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers:  85EA67068; Catalog number 5376204-50, UDI/DI 01008406821407752185EA6707411210800, Serial Numbers:  85EA67074, 85EA67067, 85EA67073; Catalog number 5376204-50-1, UDI/DI To be provided, Serial Numbers:  NT3BG1900003BH; Catalog number H3907AA, UDI/DI To be provided, Serial Numbers:   85EA67071; Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers:  85EX67007; UDI/DI To be provided, Serial Numbers:  85EA67069, 85EA67072, 85EA67079, 85EB67084;  n) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AD, UDI/DI Not Applicable, Serial Numbers:  85EZ67059, 85EA67064, 85EY67034;  o) NM/CT 860 3/8 inch: Catalog number H3908AD, UDI/DI To be provided, Serial Numbers:  00000860Z62033;  p) NM/CT 860 3/8 inch BJ: Catalog number H2408AA, UDI/DI To be provided, Serial Numbers:  NT3CG2000001BH; Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers:  NT3CG2100001BH, NT3CG1900010BH, NT3CG2100003BH, NT3CG1900005BH, NT3CG1900003BH, NT3CG2100004BH, NT3CG1900006BH, NT3CG2100005BH, NT3CG2000004BH, NT3CG1900002BH, NT3CG2100002BH;  q) NM/CT 860 3/8 inch ROW: Catalog number 5782013, UDI/DI To be provided, Serial Numbers:  00000860Y62018; Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers:  860A62056, 860Y62011, 860A62048, 860Z62039, 860Z62044, 860A62052, 860A62055, 860Y62012, 860Y62022, 860A62054; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers:  NT3CG2000003BH; UDI/DI To be provided, Serial Numbers:  860B62102;  r) NM/CT 860 ADVANCE: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers: 860Z62045, 860A62064, 860A62061; UDI/DI To be provided, Serial Numbers:  860A62075; Catalog number H3908BB , UDI/DI Not Applicable, Serial Numbers:  8BBB30002, 8BBB30001;  s) NM/CT 860 advance 3/8 inch NM Gantry: Catalog number H3908BB, UDI/DI To be provided, Serial Numbers:  8BBB30003, 8BBB30004;  t) NM/CT 860 BEYOND: Catalog number H3908BC, UDI/DI Not Applicable, Serial Numbers:  8BCB40001;   u) NM/CT 860 beyond 3/8 inch NM Gantry: Catalog number H3908BC, UDI/DI To be provided, Serial Numbers:  8BCB40002;  v) NM/CT 860 China for China: Catalog number 5376204-60-1, UDI/DI Not Applicable, Serial Numbers:  NT3CG2200004BH, NT3CG2200003BH, NT3CG2200002BH; , UDI/DI To be provided, Serial Numbers:  NT3CG2200001BH;  w) NM/CT 860 CT 860 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers:  860B62109, 860Z62029, 860B62101, 860B62113; Catalog number  H3908AD, UDI/DI Not Applicable, Serial Numbers:  860Z62036, 86EZ76001, 860A62053; UDI/DI To be provided, Serial Numbers:  860B62092, 860A62088;  x) NM/CT 860 ES 3/8 inch: Catalog number 5782013, UDI/DI To be provided, Serial Numbers:  86EB76005;   y) NM/CT 860 ES 3/8 inch ROW: Catalog number H3908AD, UDI/DI Not Applicable, Serial Numbers:  86EA76002;   z) NM/CT 850 3/8 inch: Catalog number H3907AA, UDI/DI Not Applicable, Serial Numbers:  850Y61024;   aa) NM/CT 850 ES 3/8 inch ROW: Catalog number H3907AH, UDI/DI Not Applicable, Serial Numbers:  85EY67030;   bb) NM/CT 860 3/8 inch CH: Catalog number H2408AA, UDI/DI Not Applicable, Serial Numbers:  NT3DG1900007BH;  cc) XELERIS 4 DR WORKSTATION: Catalog number 5782013, UDI/DI To be provided, Serial Numbers: 850B61124, 850A61094",
      "more_code_info": ""
    }
  ]
}