{
  "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": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72943",
      "recalling_firm": "GE Medical Systems, 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 - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.",
      "recall_number": "Z-0682-2016",
      "product_description": "Anesthesia device service kits.    ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000    ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000    ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000    ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000    ASSY-MSN, VLV ASSY DR GAS CHK  BCG, Manufacturing assembly - Buy  1503-3006-000  Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).",
      "product_quantity": "240",
      "reason_for_recall": "The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.",
      "recall_initiation_date": "20151215",
      "center_classification_date": "20160121",
      "termination_date": "20160921",
      "report_date": "20160127",
      "code_info": "11328664  11335735  11343334  11343892  11342401-2  5400168  5403740-1  5403740-2    11335499  11345497  11340364  11320301-1  11320301-2  11330567  11331744  11307341  11331786  11335845  11335293  11319820  11321192  11321193  11327291  11322915  11332821  11326031  11330266  11313876  11331340  11304929  11336322  11336553  11315455  11325139  11326345  11335028-1  11335028-2  11305735  11322211  11323901  6514379  6514380  11307579  11307579  11321258  5398226  5405405  11337945  5404884  5405628  5406602  5401553-1  5401553-2  5402221-1  5402221-2  5402221-3  5404056-1  5404056-2  5404550-1  5404550-2  5404550-3  5404550-4  5405413-1  5405413-2  5405413-3  5405699-1  5405699-2  5405699-3  11009279  5405867  5405868  5398018-1  5398018-2  5404050-1  5404050-2  5405504-1  5405504-2    11320017  11324236  11311155  11342043  5401539  5401527-1  5401527-2  5401527-3  5401527-4  11315668  5401531    11334842  11305495  11333980  11339911  11330029-2  11308028  11323566  11323905  5406531    11334842  11305495  11333980  11339911  11330029-2  11308028  11323566  11323905  5406531",
      "more_code_info": ""
    }
  ]
}