{
  "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": "Lowell",
      "address_1": "55 Technology Drive",
      "reason_for_recall": "Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written to a variable degree, with the result that it appears shifted from baseline on the system's output screen. This may, in turn, manifest as an uninterpretable ECG signal in the affected channel.",
      "address_2": "",
      "product_quantity": "43 units",
      "code_info": "Catalog number 2002021: lot numbers: EPYL0080, EPYL0118, EPZA0061,  EPZA0072, EPZA0073, EPZA0074, EPZB0043, EPZC0019, EPZC0026,  EPZC0027;  Catalog number 2002022: lot numbers: EPYL0031, EPYL0032, EPYL0033, EPYL0034, EPYL0035, EPYL0036, EPYL0037, EPYL0038, EPYL0039, EPZA0062, EPZA0063, EPZA0079, EPZA0080, EPZB0049, EPZB0050, EPZB0051, EPZB0052, EPZB0056, EPZB0057, EPZB0058, EPZB0059, EPZB0065, EPZB0066, EPZB0067,  EPZB0116, EPZB0117, EPZB0118, EPZC0018, EPZC0020, EPZC0021, EPZC0022, EPZC0023,EPZC0025, EPZD0013, EPZD0014, EPZD0015,  EPZD0016, EPZD0017;  Catalog number: 2002023: lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020;  Catalog number: 2002024; lot numbers: EPYL0082, EPYL0083, EPZA0064, EPZB0085, EPZB0119, EPZC0024, EPZD0018, EPZD0019, EPZD0020.",
      "center_classification_date": "20150618",
      "distribution_pattern": "No US distribution. Worldwide Distribution to the countries of :  Austria, Belgium, France, Germany, Great Britain, Greece, Italy, Netherlands, Poland, Romania, South Africa, Spain, Switzerland and Turkey.",
      "state": "MA",
      "product_description": "CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels,  using firmware version 2.08. The channel numbers in the amplifier are as follows:  Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021;  Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022;  Material number: H30120020230 120 Channel  CLEARSIGN II Amplifier, catalog number 2002023;  Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014.    The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information",
      "report_date": "20150624",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Boston Scientific Corporation",
      "recall_number": "Z-1817-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71398",
      "termination_date": "20161026",
      "more_code_info": "",
      "recall_initiation_date": "20150602",
      "postal_code": "01851-5203",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}