{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Waukesha",
      "address_1": "3000 N Grandview Blvd",
      "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.",
      "address_2": "",
      "product_quantity": "101 (1 US , 100 OUS)",
      "code_info": "FMI# 60857 & Descr: CARDIAC VX   Mfg Lot or Serial # System ID  00000D13194001   0000AP12171002   00000L0240862D 604682AWW4  00000287171GE3   00000322015GE9   00000287170GE5 506648AW1  00000328735GE6   00000281269GE1 604875AW1  00000LA714FC0A 562225MR2A  00000287169GE7 PASSMR1AW  00000Y13168001 M1102608  00000M13099001 RE1046AW01  00000P13074002 M4189445  00000S13081001 M4189445  00000L02687172 M2322216  00000L0240825E M2322233  00000L3A2D12BA M2322241  0000AN12171001 M155485707  0000AP12178001 M40345204  00000R13178002 M178710405  00000T13185001 M2426003  00000L13184001 M1248303  00000H13032001 A4463335  00000N13172001 M4482629  00000L13197001   00000N13030001 I9237520  00000M12341002   0000AN12171002 M2844538  0000AM12178005 C2195283  00000X12340001 C2195282  0000AM12178001 M2322247  00000M12341001 M2322247  0000AP12290001 X59655524  00000B12299001 X59655525  00000N13112001 M2148251  0000AA12213001 M4181459  0000AR12310001 M4166643  0000AD12321001 M9481854  00000R12325001 M9481855  00000M13135001   00000L020E0B14 A54013104  00000L3A3E5D1C A5624137  00000L3A5D9820 A5624137  00000H13071001 A5164528  00000LA71385A1 A5164527  0000AM12178002 A5624134  0000AA13107002 RL6035  00000P13010001 PZ0383  00000T13158001 PM0032  00000L3AB045C6 PM0278  00000X13200001   0000AM12178004 RL6025  00000V13009001 RL6059  0000AM12178003 RL6043  00000G12362001 JW0128  0000AM12178006 PMW087  0000ZA12135001 RL6009  0000AR12310002 RL6123  00000E12356001 PY0207  00000U13057001 RL6092  00000L13014001 RL6111  00000M13024001 RL6071  00000P13004001 RLW118  00000G13038001 RL6088  00000P13074001 RL6096  00000Q13092001   00000H13032002 0850270409AW1  0000AN12171003 0850270411AW1  0000AP12178002 KW1112AW03  0000AN12312001 0920499069  00000328736GE4   00000H13032003 PL1735AW08  00000L3A2CA72F PL1735AW01  00000LA71BD437 600042AW11  00000L3A2D1359 PL1751AW02  00000R12328001 PL2902AW01  00000Q13102001 PL1050AW02  00000N13022001   00000T13043001 SA1051AW03  0000AE13108001   0000AA13113001   00000R13178001   00000Z13190001   0000AF13098001 SA1255AW02  00000R13029001   00000L8B19A930 NP739729  00000V13009002 NP413434  0000AN12292001 NEV13614  0000AA13107001 O009AW11  00000A13192001   00000L026EA92D 849010AW02  00000L3A482932 266150AW04  00000L3A70D09C 120810AW02  00000LA70A3DDF 788000AW02  00000L3AB6762A 00440ADW18  00000L3AB048FE 00440ADW15  00000LA70E6008 00327ADW03  00000L13050001 00133ADW02  0000AN12171004 00249ADW01  00000Q13092002   00000LA716AE5C 317338AW5",
      "center_classification_date": "20140425",
      "distribution_pattern": "Worldwide Distribution - USA including IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM,",
      "state": "WI",
      "product_description": "GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2.    The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.",
      "report_date": "20140507",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "GE Healthcare, LLC",
      "recall_number": "Z-1511-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68032",
      "termination_date": "20140529",
      "more_code_info": "",
      "recall_initiation_date": "20140407",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}