Devices

Device Recall Xper Flex Cardio

  • Model / Serial
    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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US1724000501, US1724000507, US1619002099, US1623002117, US1624002199, US1224000035, US1201010128, US1720000448, and US1224000013
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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

Manufacturer

Invivo Corporation
  • Manufacturer Address
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Xper Flex Cardio Physiomonitoring system
  • Model / Serial
    All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Xper Flex Cardio Physiomonitoring system. || Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
  • Manufacturer
    Invivo Corporation