{
  "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": "Ongoing",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85765",
      "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",
      "recall_number": "Z-2424-2020",
      "product_description": "CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers:  2042084-001  2094504-001  2042084-001-046050  2042084-001-208621  2042084-001-045915  2042084-001-215164  2042084-001-078474  2042084-001-053034  2042084-001-215165  2042084-001-079462  2042084-001-047389  2042084-001-112198  2042084-001-041673  2042084-001-227238  2042084-001-071564  2042084-001-503824  2042084-001-119839  2042084-001-569269  2042084-001-041674  2042084-001-047549  2042084-001-514651  2042084-001-163572  2042084-001-583721  2042084-001-427592  2042084-001-527358  2042084-001-583723  2042084-001-317166  2042084-001-583724  2042084-001-583715  2042084-001-583718  2042084-001-055156  2042084-001-583722  2042084-001-041835  2042084-001-074124  2042084-001-583706  2042084-001-583707  2042084-001-519926  2042084-001-583717  2042084-001-583713  2042084-001-207863  2042084-001-460604  2042084-001-079192  2042084-001-197663  2042084-001-045872  2042084-001-053195  2042084-001-092010  2042084-001-560824  2042084-001-052372  2042084-001-071088  2042084-001-046667  2042084-001-213006  2042084-001-086202  2042084-001-301821  2042084-001-045720  2042084-001-060454  2042084-001-418294  2042084-001-088907  2042084-001-065769  2042084-001-589530  2042084-001-623792  2042084-001-187563  2042084-001-320333  2042084-001-357143  2042084-001-148302  To be provided  2042084-001-082825  2042084-001-057016  2042084-001-153601  2042084-001-161552  2042084-001-140229  2042084-001-611704  2042084-001-626688  2042084-001-389208  2042084-001-657836  2042084-001-225214  2042084-001-503162  2042084-001-477881  2042084-001-316025  2042084-001-046826  2042084-001-245255  2042084-001-196543  2042084-001-557725  2042084-001-505890  2042084-001-218596  2042084-001-336980  2042084-001-524525  2042084-001-600032  2042084-001-529732  2042084-001-195742  2042084-001-195782  2042084-001-573889  2042084-001-573890  2042084-001-573886  2042084-001-573887  2042084-001-195822  2042084-001-195862  2042084-001-048420  2042084-001-065538  2042084-001-055814  2042084-001-341260  2042084-001-149220  2042084-001-079193  2042084-001-229282  2042084-001-629486  2042084-001-058695  2042084-001-061170  2042084-001-629548  2042084-001-080803  2042084-001-596662  2042084-001-250146  2042084-001-202515  2042084-001-515709  2042084-001-579491  2042084-001-505608  2042084-001-065010  2042084-001-619171",
      "product_quantity": "89,109 units",
      "reason_for_recall": "The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.",
      "recall_initiation_date": "20200518",
      "center_classification_date": "20200623",
      "report_date": "20200701",
      "code_info": "All Model Numbers that contain software versions 2.6 or 2.7"
    }
  ]
}