Devices

Device Recall Xper Flex Cardio

  • Modèle / numéro de série
    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, US1611001828,  US1611001832, US1611001848, US1611001863, US1505000508,  US1505000528, US1505000529, US1505000540, US1534001217,  US1720000386, US1720000407, US1720000409, US1720000416,  US1720000419, US1720000422, US1720000427, US1720000428, US1446000242, US1244000010, US1251000075, US1224000034, US1244000048, US1608001665, US1609001701, US1609001702, US1609001703, US1609001704, US1609001706, US1609001707,  US1609001708, US1609001709, US1609001712, US1609001714,  US1609001722, US1609001727, US1609001729, US1652000009,  US1652000025, US1652000037, US1652000045, US1652000052, US1652000062, US1652000064, US1652000066, US1248000057, US1331000025, US1331000053, US1331000063, US1331000050,  US1331000069, US1331000070, US1334000001, US1331000001, US1331000002, US1331000003, US1331000012, US1331000022, US1238000001, US1202010150, US1304000045, US1325000027, US1328000007, US1328000008, US1334000025, US1343000049, US1331000007, US1446000243, US1446000287, US1450000325 US1431000040, US1433000064, US1433000067, US1537001311, US1537001331, US1547001372, US1550001454, US1550001472, US1550001476, US1550001484, US1407000012, US1244000068, US1248000007, US1248000010, US1248000015, US1248000024, US1248000030, US1251000023, US1239000014, US1203010353, US1202010152, US1202010198, US1202010212, US1202010235, US1203010374, US1203010395, US1202010180, US1202010181,  US1202010184, US1202010185, US1202010187, US1202010190, US1202010192, US1202010195, US1107010004, US1248000031,  US1248000042, US1248000046, US1248000050, US1248000059,  US1502000401, US1502000409, US1502000427, US1502000431,  US1502000433, US1502000435, US1502000437, US1502000447,  US1502000449, US1502000452, US1438000148, US1505000480,  US1343000022, US1107010035, US1109010082, US1109010087,  US1109010091, US1109010100, US1505000499, US1505000541,  US1505000542, US1443000235, US1446000245US1446000276 US1324000023, US1324000047, US1325000013, US1325000014, US1325000001, US1325000003, US1325000021, US1224000039, US1331000023, US1343000089, US1611001820, US1611001876, US1611001888, US1611001916, US1613001928, US1613001932,  US1613001947, US1613001950, US1613001957, US1613001967, US1613001969, US1613001971, US1708000102, US1708000110, US1708000126, US1709000263, US1716000304, US1537001302,  US1534001159, US1534001184, US1534001188, US1547001362, US1547001387, US1547001399, US1547001400, US1547001403, US1547001405, US1608001636, US1608001637, US1608001638,  US1608001641, US1608001642, US1608001643, US1608001644,  US1608001652, US1608001656, US1517000663, US1517000672,  US1517000677, US1517000682, US1517000684, US1304000035,  US1311000036, US1251000090, US1251000092, US1251000093,  US1251000095, US1251000096, US1304000008, US1304000010,  US1304000014, US1304000019, US1304000029, US1304000030,  US1304000039, US1251000080, US1251000081, US1251000083  US1251000091, US1304000021, US1304000023, US1304000024,  US1248000081, US1311000082, US1517000651, US1108010045,  US1610001780, US1610001783, US1610001786, US1610001787,  US1610001789, US1610001792, US1610001793, US1610001794, US1608001645, US1608001651, US1608001654, US1608001672, US1608001673, US1608001677, US1608001679, US1608001682,  US1724000543, US1724000485, US1724000499, US1724000510,  US1724000521, US1724000523, US1724000526, US1724000530,  US1724000535, US1724000538, US1724000546, US1724000559,  US1251000086, US1248000037, US1251000072, US1304000004,  US1324000027, US1324000042, US1325000012, US1325000018, US1328000003, US1343000016, US1324000019, US1244000041, US1720000382, US1720000405, US1720000456, US1724000463, US1724000464, US1724000473, US1724000480, US1724000482,  US1529001083, US1529001090, US1534001196, US1534001204, US1537001293, US1412000045, US1720000444, US1224000016, US1408000011, US1408000041, US1412000032, US1412000041, US1417000009, US1417000010, US1417000029, US1518000751, US1523000816, US1617001988, US1619002078, US1619002080, US1619002083, US1202010183, US1304000018, US1231000033, US1231000057, US1231000084, 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, US1311000027, US1311000033, US1311000035, US1311000038, US1311000043,  US1311000045, US1311000047, US1311000048, US1224000017, US1239000039, US1708000115, US1638002529, US1638002545, US1638002556, US1638002567, US1638002572, US1638002574, US1638002578, US1638002579, US1638002583, US1638002584,  US1638002586, US1638002588, US1638002595, US1638002493,  US1638002483, US1638002494, US1638002499, US1638002508,  US1638002486, US1248000073, US1251000006, US1202010206, US1334000022, US1407000040, US1407000048, US1407000053, US1407000056, US1407000060, US1433000079, US1433000081, US1438000111, US1438000119, US1438000121, US1438000126, US1438000128, US1438000132, US1438000140, US1438000141, US1438000142, US1438000143, US1438000149, US1517000676, US1625002315, US1626002374, US1626002379, US1626002405, US1626002406, US1325000005, US1331000011, US1343000019, US1324000016, US1248000075, US1608001626, US1202010161,  US1248000058, US1248000067, US1248000068, US1248000070, US1248000072, US1251000003, US1251000012, US1251000015, US1251000016, US1248000005, US1547001384US1311000076, US1343000088, US1108010044, US1611001817, US1407000020, US1407000027, US1408000015, US1251000085, US1626002469, US1626002470, US1626002471, US1638002481, US1638002500, US1638002507, US1638002514, US1638002523, US1638002534,  US1502000414, US1502000428, US1517000656, US1450000326, US1324000048, US1231000017, US1502000444US1107010018 US1107010000, US1108010048, US1109010079, US1625002279, US1203010341, US1203010420, US1203010283, US1319000085, US1534001193, US1534001195, US1534001209, US1534001215, US1352000041, US1407000046, US1352000035, US1419000035, US1248000002, US1248000014, US1248000026, US1251000014, US1331000056, US1613001951, US1441000158, US1443000201, US1443000221, US1443000224, US1443000226, US1443000227, US1443000228, US1443000230, US1443000233, US1446000241, US1446000260, US1446000261, US1446000279, US1408000018, US1224000006, US1224000010, US1224000036, US1224000052, US1108010052, US1238000007, US1613001931, US1613001933, US1613001935, US1611001867, US1611001869, US1611001891, US1611001895, US1611001896, US1611001900, US1611001920, US1613001934, US1613001940, US1613001949, US1652000005, US1652000008, US1652000034, US1652000035US1652000063, US1708000113, US1708000203, US1638002495, US1638002504, US1638002524, US1638002533, US1337000025, US1343000075, US1343000085, US1343000086, US1343000087, US1352000001, US1352000028, US1352000032, US1352000042, US1352000060, US1337000041, US1334000039, US1609001718, US1609001719, US1609001738, US1609001739, US1609001743, US1610001749, US1610001750, US1610001757, US1608001678, US1505000514, US1611001906, US1611001924, US1334000019, US1331000062, US1517000717, US1517000725, US1517000726, US1518000742, US1518000743, US1518000746, US1517000712, US1517000713, US1517000715US1517000716 ,US1517000738, US1518000744, US1518000773, US1518000774, US1518000775, US1438000110, US1419000026, US1441000162, US1502000388, US1517000679, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

Invivo Corporation
  • Adresse du fabricant
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

Device Recall Xper Flex Cardio Physiomonitoring system
  • Modèle / numéro de série
    All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    Xper Flex Cardio Physiomonitoring system. || Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
  • Manufacturer
    Invivo Corporation