{
  "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": "Terminated",
      "city": "Snoqualmie",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69223",
      "recalling_firm": "Spacelabs Healthcare Inc",
      "address_1": "35301 SE Center St",
      "address_2": "N/A",
      "postal_code": "98065-9216",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.",
      "recall_number": "Z-2707-2014",
      "product_description": "Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.    Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.     Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed",
      "product_quantity": "82 units distributed in US and 140 units distributed outside US",
      "reason_for_recall": "The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally.    The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).",
      "recall_initiation_date": "20140826",
      "center_classification_date": "20140925",
      "termination_date": "20150626",
      "report_date": "20141001",
      "code_info": "The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US.  These 15 units will receive serial numbers after the software upgrade is installed.     THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US:    040-1548-00,  1367-000033,  1369-001517,  1369-003051,  1369-003077,  1369-004247,  1369-005914,  1369-006877,  1369-007165,  1369-008519,  1369-010292,  1369-011637,  1369-017520,  1369-061217,  1370-000013,  1370-000014,  1370-000025,  1370-000095,  1370-000285,  1370-000449,  1370-000471,  1370-000579,  1370-000658,  1370-001700,  1370-002494,  1370-002510,  1370-003785,  1370-004176,  1370-004184,  1370-004275,  1370-004292,  1387-000465,  1387-000535,  1387-000543,  1387-001071,  1387-001677, 1387-006200,  1387-010824,  1387-010830,  1387-011914,  1387-014142,  1387-014159,  1387-014184,  1387-014186,  1387-014187,  1387-014188,  1387-014596,  1387-015721,  1387-015722,  1387-015723,  1387-016045,  1387-018424,  1387-018947,  1387-019766,  1387-019768,  1387-019769,  1387-019771,  1387-019772,  1387-100036,  1387-101646,  1387-104672,  1387-105801,  1387-105811,  1387-105812,  1387-105882,  1393-000442,  1393-000579,  1393-000580,  1393-000581,  1393-000582,  and 387-002421.      THERE ARE 137 SERIAL NUMBERS IDENTIFIED ON UNITS DISTRIBUTED OUTSIDE OF THE US:    1369-000011, 1369-000165, 1369-000407, 1369-000928, 1369-002976, 1369-003388, 1369-005316, 1369-005334, 1369-006100, 1369-006281, 1369-007338, 1369-009142, 1369-009143, 1369-009144, 1369-009145, 1369-009146, 1369-009889, 1369-009890, 1369-011741, 1369-011742, 1369-011743, 1369-011744, 1369-011745, 1369-013721, 1369-016648, 1369-016649, 1369-017759, 1369-017791, 1369-017792, 1370-000026, 1370-000725, 1370-000771, 1370-002373, 1370-002378, 1370-002380, 1370-002381, 1370-002382, 1370-002383, 1370-002384, 1370-003809, 1370-004133, 1370-004277, 1370-004509, 1370-004510, 1370-004511, 1370-004516, 1370-004617, 1370-200366, 1370-200370, 1370-200374, 1370-200375, 1370-200376, 1370-200378, 1370-200380, 1370-200471, 1370-200473, 1370-200474, 1370-200475, 1370-200476, 1370-200691, 1387-000044, 1387-000447, 1387-000467, 1387-000548, 1387-001086, 1387-002157, 1387-005006, 1387-008003, 1387-008310, 1387-010742, 1387-013241, 1387-013716, 1387-014610, 1387-018104, 1387-018105, 1387-018171, 1387-018176, 1387-018277, 1387-018638, 1387-018817, 1387-019563, 1387-100148, 1387-100150, 1387-100151, 1387-100155, 1387-100906, 1387-101061, 1387-101062, 1387-101063, 1387-101064, 1387-101065, 1387-101066, 1387-101067, 1387-102222, 1387-103550, 1387-103659, 1387-104462, 1387-105831, 1387-105832, 1387-105833, 1387-105834, 1393-000013, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000808, 1393-000809, 1393-000822, 1393-000831, 1393-000833, 1393-000834, 1393-000851, 1393-000852, 1393-00235, 1393-00236, 1393-00237, 1393-00238, 1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346, 1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351, 1393-00352, 1393-00353, 1393-00354, AND 1393-00355."
    }
  ]
}