{
  "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": [
    {
      "country": "United States",
      "city": "Plainsboro",
      "address_1": "311 Enterprise Dr",
      "reason_for_recall": "Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed.  But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.",
      "address_2": "",
      "product_quantity": "275 CAM01 Monitors",
      "code_info": "MEK1200104  MEK1200204  MEK1200304  MEK1200404  MEK1200504  MEK1200604  MEK1200704  MEK1200804  MEK1200904  MEK1201004  MEK1201104  MEK1201204  MEK1201304  MEK1201404  MEK1201504  MEK1201604  MEK1201704  MEK1201804  MEK1201904  MEK1202004  MEL1200104  MEL1200204  MEL1200304  MEL1200404  MEL1200504  MEL1200604  MEL1200704  MEL1200804  MEL1200904  MEL1201004  MEL1201104  MEL1201204  MEL1201304  MEL1201404  MEL1201504  MEL1201604  MEL1201704  MEL1201804  MEL1201904  MEL1202004  MEL1202104  MEL1202204  MEL1202304  MEL1202404  MEL1202504  MEL1202604  MEL1202704  MEL1202804  MEL1202904  MEL1203004  MEL1203104  MEL1203204  MEL1203304  MEL1203404  MEL1203504  MEL1203604  MEL1203704  MEL1203804  MEL1203904  MEL1204004  MEL1204104  MEL1204204  MEL1204304  MEL1204404  MEL1204504  MEL1204604  MEL1204704  MEL1204804  MEL1204904  MEL1205004  MEM1200104  MEM1200204  MEM1200304  MEM1200404  MEM1200504  MEM1200604  MEM1200704  MEM1200804  MEM1200904  MEM1201004  MEM1201104  MEM1201204  MEM1201304  MEM1201404  MEM1201504  MEM1201604  MEM1201704  MEM1201804  MEM1201904  MEM1202004  MEM1202104  MEM1202204  MEM1202304  MEM1202404    MEM1202504  MEM1202604  MEM1202704  MEM1202804  MEM1202904  MEM1203004  MEM1203104  MEM1203204  MEM1203304  MEM1203404  MEM1203504  MEM1203604  MEM1203704  MEM1203804  MEM1203904  MEM1204004  MEA1300104  MEA1300204  MEA1300304  MEA1300404  MEA1300504  MEA1300604  MEA1300704  MEA1300804  MEA1300904  MEA1301004  MEA1301104  MEA1301204  MEA1301304  MEA1301404  MEA1301504  MEA1301604  MEA1301704  MEA1301804  MEC1300104  MEC1300204  MEC1300304  MEC1300404  MEC1300504  MEC1300604  MEC1300704  MEC1300804  MEC1300904  MEC1301004  MEC1301104  MEC1301204  MEC1301404  MEC1301504  MEC1301604  MEC1301704  MEC1301804  MEC1301904  MEC1302004  MED1300104  MED1300204  MED1300304  MED1300404  MED1300504  MED1300604  MED1300704  MED1300804  MED1300904  MED1301004  MED1301104  MED1301204  MED1301304  MED1301404  MED1301504  MED1301604  MED1301704  MED1301804  MED1301904  MED1302004  MEE1300104  MEE1300204  MEE1300304  MEE1300404  MEE1300504  MEE1300604  MEE1300704  MEE1300804  MEE1300904  MEE1301004  MEE1301104  MEE1301204  MEE1301304  MEE1301404  MEE1301504  MEE1301604  MEE1301704  MEE1301804  MEE1301904  MEE1302004  MEE1302104    MEE1302204  MEE1302304  MEE1302404  MEE1302504  MEE1302604  MEE1302704  MEE1302804  MEE1302904  MEE1303004  MEE1303104  MEE1303204  MEF1300104  MEF1300204  MEF1300304  MEF1300404  MEF1300504  MEF1300604  MEF1300704  MEF1300804  MEF1300904  MEF1301104  MEF1301204  MEF1301304  MEF1301404  MEF1301504  MEF1301604  MEF1301704  MEF1301804  MEF1301904  MEF1302004  MEF1302104  MEF1302204  MEF1302304  MEF1302404  MEF1302504  MEF1302604  MEF1302704  MEF1302804  MEF1302904  MEF1303004  MEF1303104  MEF1303204  MEF1303304  MEF1303404  MEF1303504  MEF1303604  MEF1303704  MEF1303804  MEF1303904  MEF1304004  MEF1304104  MEF1304204  MEF1304304  MEF1304404  MEF1304504  MEF1304604  MEF1304704  MEF1304804  MEF1304904  MEF1305004  MEF1305104  MEF1305204  MEF1305304  MEF1305404  MEG1300104  MEG1300204  MEG1300304  MEG1300404  MEG1300504  MEG1300604  MEG1300704  MEG1300804  MEG1300904  MEG1301004  MEG1301304  MEG1301404  MEG1301504  MEG1301604  MEG1301704  MEG1301804  MEG1301904  MEG1302004  MEG1302104  MEG1302204  MEH1300104  MEH1300204  MEH1300304",
      "center_classification_date": "20131227",
      "distribution_pattern": "Worldwide Distribution - USA ( Nationwide ) and the countries of : UK, Saudi Arabia, South Africa, Brunei, China, France, Poland, Turkey, Greece, Sweden, United Arab Emirates, Russia, Spain, Pakistan, Finland, Israel, Italy, Slovenia, Japan, Poland, Malaysia, Germany and Panama.",
      "state": "NJ",
      "product_description": "Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA    The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems.",
      "report_date": "20140108",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integra LifeSciences Corp.",
      "recall_number": "Z-0602-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67094",
      "termination_date": "20150213",
      "more_code_info": "",
      "recall_initiation_date": "20131126",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}