{
  "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": "2026-04-15",
    "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": "72301",
      "recalling_firm": "GE Healthcare",
      "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 - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.",
      "recall_number": "Z-0257-2016",
      "product_description": "GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device.  It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.",
      "product_quantity": "97",
      "reason_for_recall": "When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.",
      "recall_initiation_date": "20150831",
      "center_classification_date": "20151109",
      "termination_date": "20180907",
      "report_date": "20151118",
      "code_info": "002005-1018-15 352333MR3T  000006-0523-13 716859MR3T  00001003BD6425 352376MR3T2  00000280001MR9 MR129031  00000285499MR0 2154563TMR  000000HDMR3702 RADNETMR554  00000274930MR7 805CHLIMR1  00000280057MR1 513558MR3T  00000274998MR4 213977MR2  002004-0713-06 ACB41109MR  002004-0406-08 323442MR2  002004-0406-15 323442MR1  00000273396MR2 7326133T  002004-1115-19 865373MR1  002005-0316-05 7576713T  0002005-0606-4 205750MR2  00000274839MR0 9287573TMR  002006-0119-15 559325CIIMR1  0002005-1201-3 256734MR3T  002005-1003-15 201487MR  000000HDMR2996 6053223TMR  000000HDMR3245 775RDC3T  002005-0620-16 405634S3T  00000269460MR2 602406IMR  00000275670MR8 813972VAMR  0002005-1121-7 480614MR1  00000273230MR3 602689MR1  002005-1201-20 601288MR3T  00000275936MR3 ALLIANCESIG463  00000275086MR7 650306SMR3T  00000275162MR6 772VRAMR3T  00000273459MR8 360397MR2  0002005-0104-5 662841MR4  000006-0511-20 336852SEMR  00000278626MR7 228KAFBMR3T  00000278619MR2 806212MR3T  00000278722MR4 337261MR1  00000281703MR9 916DR3TMR  0002005-0511-5 203797MR3T  002005-1115-04 615342MR3T  00000282868MR9 504873TMR3  00000281682MR5 859275MR3T  000000HDMR5653 RADNETMR608  00000000036657 480584MR1  #N/A TRAINING789  N/A 201669MR2  00000278623MR4 972378NSC3TMR1  00000267322MR6 920568MR3T  00000273365MR7 503280MR2  0002005-1201-6 865541MR3T  00000086257DP3 901516U3T  00000264748MR5 0910277003  00000268123MR7 0910272046   AZ1003MR02  00000282790MR5 082427090245  00000285380MR2 082427100084  00000286559MR0 082427090090  00000286800MR8 082427100089  00000287879MR1 082427040076  00000288667MR9 082427070050  00000289798MR1 082427100093  00000261198MR6 082427210039  00000262803MR0 082427070034  00000262931MR9 082427040047  00000265593MR4 082427160041  00000266147MR8 082427040061  00000267973MR6 082427040052  00000270974MR9 082427100064  00000271233MR9 082427040046  00000272894MR7 082427140039  00000273229MR5 082427120044  00000277189MR7 082427160049  290392MR0¿¿¿¿¿¿¿¿¿¿  082427270017  00000265589MR2 DK1083MR04  00000000WB0692 ET1009MR01  00000262460MR9 0828270021IB01  00000270245MR4 0828270023  00000272433MR4 083027002101706  N/A 083027202101396  00000275668MR2 IR1503MR01  00000279077MR2 KW1004MR03  00000262791MR7 56MRE3TH2565370  00000280669MR3 0920279025  00000309597MR3 NO1011MR01  00000272533MR1 787840CIRT3T  00000276591MR5 787653MR3T  00000279460MR0 787740MR3T  00000275845MR6 RU1283MR01  00001002BD637F MEX68900  00000HDMR10201 GP178328  00000275642MR7 GEE34040  000000000WB658 MPX10000  00000266820MR0 387040MR06  00000262456MR7 34208MRS01  00000271120MR8 34006MRS03  00000266270MR8 10146MRS03  00000274693MR1 3882630908MRMET"
    }
  ]
}