{
  "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": [
    {
      "status": "Terminated",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71211",
      "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 including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.",
      "recall_number": "Z-1606-2015",
      "product_description": "GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).",
      "product_quantity": "110 (83 units US, 27 units OUS)",
      "reason_for_recall": "The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patient¿s condition and delayed or missed life sustaining patient treatment",
      "recall_initiation_date": "20150504",
      "center_classification_date": "20150512",
      "termination_date": "20150915",
      "report_date": "20150520",
      "code_info": "Mfg Lot or Serial #  SED12394685GA  SED12394688GA  SED12404710GA  SED12404711GA  SED12404713GA  SED12404716GA  SED12404718GA  SED12404720GA  SED12404721GA  SED12404722GA  SED12404723GA  SED12404725GA  SED12445258GA  SED12445259GA  SED12445261GA  SED12445262GA  SED12445264GA  SED12445265GA  SED12445266GA  SED12445268GA  SED12445269GA  SED12445298GA  SED12445299GA  SED12445309GA  SEW12265533HA  SEW13286489HA  SEW14095097HA  SEW14095105HA  SEW14105496HA  SEW14105497HA  SEW14105502HA  SEW14105503HA  SEW14160623HA  SEW14160626HA  SEW14171213HA  SEW14171313HA  SEW14171314HA  SEW14171315HA  SEW14171317HA  SEW14171319HA  SEW14171320HA  SEW14171321HA  SKA14062508GA  SKA14062511GA  SKA14284377GA  SKA14284378GA  SKA14284382GA  SKA14284385GA  SKA14284388GA  SKA14284393GA  SKA14284394GA  SKA14284395GA  SKA14365356GA  SKA14365375GA  SKA14365378GA  SKA14365380GA  SKA14365382GA  SKA14487159GA  SKA14487160GA  SKA14487161GA  SKA14487162GA  SKA14487163GA  SKA14487165GA  SKA14487166GA  SKA14487168GA  SKA14487170GA  SKA14487171GA  SKA14487172GA  SKA14487173GA  SKA14487174GA  SKA14487175GA  SKA14487176GA  SKA14487178GA  SKA14487180GA  SKA14487182GA  SKA14487185GA  SKA14487218GA  SKA15038500GA  SKA15048558GA  SMV15123913HA  SMV15145547HA  SMV15145548HA  SMV15124159HA  SEW12018091HA  SKA13390428GA  SKA13390435GA  SKA13390440GA  SKA13390468GA  SKA13390474GA  SKA13430502GA  SKA13430503GA  SKA13430504GA  SKA13430505GA  SMV15123911HA  SED11067045GA  SED12394559GA  SKA14092755GA  SMV15123912HA  SED11229605GA  SED11239640GA  SED11239644GA  SED11239645GA  SED11239663GA  SED11239664GA  SED11239668GA  SED11239669GA  SED11239678GA  SED11239679GA  SED11239680GA  SMV15123915HA",
      "more_code_info": ""
    }
  ]
}