Devices

Device Recall Xper Flex Cardio

  • 모델명 / 제조번호(시리얼번호)
    MODEL #(s):  453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375,  US1203010398, US1203010407, US1304000043, US1304000046,  US1224000050, US1550001470, US1251000063, US1109010070,  US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396,  US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478,  US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005,  US1231000060, US1537001268, US1537001272, US1537001276, US1537001277, US1537001280, US1537001338, US1202010174,  US1417000023, US1419000042, US1412000038, US1419000004,  US1419000023, US1419000052, US1424000010, US1424000018, US1431000027, US1239000034, US1550001491, US1338000001,  US1550001502, US1550001468, US1611001807, US1611001814,  US1611001826, US1611001831, US1611001850, US1248000004,  US1248000025, US1248000028, US1248000035, US1517000665,  US1517000671, US1517000680, US1443000225, US1724000551,  US1724000561, US1729000573, US1729000601, US1729000604,  US1311000065, US1407000058, US1334000037, US1224000027,  US1304000017, US1517000691, US1517000696, US1352000036, US1652000003, US1652000011, US1652000016, US1652000042, US1505000498, US1505000518, US1505000567, US1337000007, US1337000008, US1343000057, US1352000052, US1203010408,  US1511000639, US1534001157, US1534001158, US1534001163, US1534001165, US1534001167, US1534001171, US1534001220,  US1534001223, US1534001226, US1534001229, US1534001230,  US1534001232, US1534001233, US1534001237, US1537001259,  US1537001265, US1324000046, US1443000180, US1613001985, US1617002038, US1619002059, US1619002079, US1619002081, US1517000666, US1517000669, US1517000685, US1407000059, US1441000164, US1443000181, US1443000195, US1441000163,  US1502000477, US1529001080, US1224000020, US1231000023,  US1231000035, US1231000064, US1231000081, US1231000083,  US1234000001, US1234000004, US1234000006, US1234000055,  US1352000017, US1352000023, US1352000024, US1304000041, US1352000059, US1107010009, US1107010013, US1107010014, US1108010043, US1108010057, US1109010073, US1352000062, US1407000038, US1407000041, US1408000002, US1716000343,  US1716000344, US1716000345, US1720000353, US1720000354,  US1720000363, US1709000268, US1525000986, US1525000991,  US1529000995, US1529001027, US1529001033, US1529001068,  US1107010034, US1109010069, US1201010136, US1505000478,  US1505000511, US1505000513, US1505000546, US1343000092,  US1417000006, US1443000219, US1638002490, 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US1234000014, US1234000062, US1239000021, US1450000351, US1450000357, US1505000556, US1550001463, US1550001473, US1550001479, US1550001500,  US1550001505, US1608001640, US1611001913, US1611001914, US1611001917, US1613001943, US1613001961, US1613001968, US1613001970, US1613001976, US1613001979, US1613001980,  US1613001981, US1613001982, US1617001997, US1617002005,  US1617001989, US1617001991, US1619002071, US1619002076, US1619002077, US1619002103, US1619002105, US1334000038, US1334000045, US1334000043, US1251000011, US1203010257, US1203010262, US1441000165, US1443000166, US1443000171, US1443000172, US1443000202, US1443000205, US1443000208,  US1203010260, US1203010287, US1203010325, US1203010336,  US1203010362, US1203010363, US1203010271, US1203010294, US1203010322, US1203010383, US1203010298, US1203010315, US1203010319, US1203010364. US1505000482. US1505000502.  US1505000509, US1505000565, US1108010060, US1201010147, US1407000016, US1224000004, US1224000021, US1224000037, US1224000041, US1224000046, US1244000003, US1224000003, US1224000024, US1231000012, US1231000031, US1231000052,  US1231000069, US1231000078, US1234000003, US1234000016, US1234000020, US1239000046, US1407000024, US1319000011,  US1724000492, US1724000537, US1724000548, US1201010124,  US1201010134, US1201010139, US1201010140, US1201010142,  US1337000023, US1337000029, US1343000005, US1343000028,  US1343000033, US1343000039, US1343000061, US1343000084,  US1343000025, US1324000004, US1446000248, US1450000323, US1502000426, US1502000441, US1505000569, US1547001441, US1604001573, US1604001625, US1244000025, US1202010148, US1202010154, US1202010178, US1202010204, US1202010237,  US1547001367, US1708000116, US1716000346, US1716000347, US1720000355, US1720000358, US1720000377, US1720000378, US1720000421, US1720000423, US1720000430, US1720000431, US1720000435, US1720000436, US1720000437, US1720000439, US1407000063, US1550001469, US1408000036, US1202010234,  US1625002311, US1625002324, US1625002333, US1625002338, US1729000572, US1729000588, US1729000600, US1729000606, US1331000047, US1352000015, US1352000045, US1352000054, US1352000057, US1623002112, US1619002049, US1623002116, US1623002118, US1623002141, US1623002144, US1623002147, US1623002150, US1623002151, US1623002155, US1623002159, US1623002176, US1624002198, US1624002206, US1624002209, US1624002223, US1625002226, US1505000484, US1505000487, US1505000488, US1505000494, US1505000497, US1505000523, US1505000524, US1505000531, US1505000564, US1505000566,  US1626002468, US1638002480, US1638002485, US1638002489, US1638002491, US1638002501, US1638002515, US1638002518, US1613001963, US1617001987, US1518000806, US1625002344, US1626002375, US1626002380, US1626002388, US1626002389,  US1626002403, US1626002413, US1626002416, US1626002438, US1626002460, US1626002464, US1311000012, 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  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.
  • 제품 설명
    Xper Flex Cardio Physiomonitoring System || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.
  • Manufacturer
    Invivo Corporation
  • 1 Event

제조사

Invivo Corporation
  • 제조사 주소
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Xper Flex Cardio Physiomonitoring system
  • 모델명 / 제조번호(시리얼번호)
    All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen
  • 제품 설명
    Xper Flex Cardio Physiomonitoring system. || Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
  • Manufacturer
    Invivo Corporation