{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62760",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "address_2": "N/A",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally to:  AUSTRALIA, AZERBAIJIN, BAHRAIN, BELARUS, BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, JAPAN, KUWAIT, LEBANON, LIBYA, MALAYSIA, MEXICO, POLAND, PORTUGAL, ROMANIA, RUSSIA, SA¿DI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, and YEMEN.",
      "recall_number": "Z-2376-2012",
      "product_description": "GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems.  K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.",
      "product_quantity": "240 (133 US and 107 OUS)",
      "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems.     While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.",
      "recall_initiation_date": "20120816",
      "center_classification_date": "20120913",
      "termination_date": "20151020",
      "report_date": "20120919",
      "code_info": "System ID (As required)  910162015  AZ4001VA01  BH1000VA01  BY4033VA01  BY4020VA02  BG4549VA01  BG4009VA01  416480INNOVA2  HSRINNOVA1  82416070010  82416150007  82416210022  82416040046  CS1006VA05  EG1000VA01  M4198064  N4192939  M4166990  M4212443  HC1819XR10  HC5284XR39  542120XR02  HC5284XR38  83016862100448  835160028  IQ1165VA02  IE1100VA03  A5632421  A5102694  A5379605  A5320145  B5114298  A5360408  YV0370  YV0365  YV0364  YV0166  YV0369  YV0473  YV0480  YV0478  YV0475  YV0362  YV0510  YV0474  YV0481  YV0367  YV0477  YV0388  YV0466  YV0500  YV0463  YV0476  YV0464  YV0462  YV0400  YV0366  YV0501  YV0520  YV0363  YV0555  YV0472  YV0471  YV0470  YV0469  YV0468  YV0467  KW1098VA01  KW1098VA02  KW1011VA02  LB1331VA01  LY1086VA01  834160006  834160005  834160004  INNOVA2948687  PL1804VA01  PER18124  RO1095VA01  RU3427VA01  RU2741VA04  RU3847VA01  RU3883VA01  NA  SA2253VA01  SA2236VA01  847160005  847160006  850060744  850060739  MEX68922  853060209  853060201  853060200  853060198  853060202  856160010  AE1225VA01  00234VAS02  00095VAS08  05448VAS01  00440VAS04  10086VAS07  10307VAS01  00243VAS02  00026VAS01  256HHCIB1  205877CCL3  480512BP  8184093131  6263973131  415206IBP1X53  3108252121A  3108252121B  909LLUMC2121  661949INNOVA3  650493BIPL  510428BIPL  619543INNOVABP  CHLDRNCL1  303436LCLP  303425CL2  2036882121  FHORLEP4  561548BIP  561495DLBIP  FHORLEP5  FHORL3131  904202WCL1  561881BP1  561881BP2  808547QCV4  319272EP  208227INNOVA31  630856H3131  630933INVLAB4  309655FSP4A  773RES3131BP  309655FSP2B  219326EP1  812238UNBPL  317338PV4  317338CL4BP  2197383131  2192632121  2198362121  913541OP3131  316268BIPLANE  504842OMC3131  504842OMCEP2  504842OMCEP1  504897INNOVA2  985867INNOVA31  617636IN2121  857307IN12121  857307IN22121  617525IN13131  857307IN32121  410614CV2  410614CV1  4105502121  410740CV  3018912121  202782LABA  301295EP  301295CATH  616392BP  507385INN3131  612273INNOVA3  816698CP3131  816932SL3131  704355RM7  704355P2121  603650EP1  973971EP3  973972LAB3  7327762121  7323213131  505887CL1  7028533131  718579INNOVABP  516562INNOVA1  718226BP1  COR373252  COR373301  COR373295  ORMCIR2  518262BP1  5135843131  541743CL5  503OHSUCV4  503OHSUCV3  541743CL2  541382BP  570824BP1  215576INNOVA2  LVINOV6  610526LAB3  814877BP  215662INNOVA3  412623H  610954BP1  864512EPBP  843692GSBPEP  615284ANG2  615222BIH  615222BIG  615769SP1  956632INN3131  281637SL3131  832522MW3131  903CSM2121  817465AR3131  361857CATH2  VAD2121  BMANGIO  936539CL4  936WH2121  214590EP2121  BMEP  713794LAB8  832355LAB4  713794LAB11  281440BP31  210617VACATH1  MCDEP  801532LCA  540776LGVAS2  276258INV3131  434654CATH2121  253627INNOVA5  206598UWBP  253403CL4  509474BIP  509473RM1  4146492121  4144473131  ECXV1402B  304526INNOVABP  YE1002VA01"
    }
  ]
}