510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2115-2018Class II

Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate...

Invivo Corporation / initiated 2017-11-20 / Open, Classified / root cause: software
FDA source (opens on fda.gov)

Invivo Corporation began a recall of Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular... on . FDA classified it as Class II and gives the reason as "While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-2115-2018
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Invivo Corporation
Product
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.
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
Root cause tag
software
FDA root cause
Software design
Action
The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated November 2017 and Field Safety Notice to each known affected customer. The letter describes the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The customers were instructed to do the following: Follow the Action to be Taken by Customer/User section of the Field Safety Notice as follows: -You may continue to use the device provided that each monitored patient in the Pre or Post-Op Holding Area is closely observed by a qualified health care professional and is not left unattended, as specified in the devices instructions for use. The most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Also, users should always immediately respond to all audible alarms given by the device. Until your device can be corrected, please inform users of the content of this notice and instruct them that to properly exit Full Disclosure playback, use the X icon in the upper right corner of the Full Disclosure Playback control window and do not use the ESC key function. A Philips representative will contact you regarding any affected PCC modules. Each affected PCC will require a software update by Philips. Additionally, all Software and Documentation Media Kits will be replaced. This corrective action will be implemented free of charge by Philips. If you need any further information or support concerning this problem, please contact your local Philips representative: 800-669-1328 option 2, then option 3.
Quantity in commerce
1,040 units (USA) and 7 units (Foreign)
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 codes and lots
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, US1446000245 US1446000276 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, US1547001384 US1311000076, US1343000088, US1108010044, US1611001817, US1407000020, US1407000027, US1408000015, US1251000085, US1626002469, US1626002470, US1626002471, US1638002481, US1638002500, US1638002507, US1638002514, US1638002523, US1638002534,  US1502000414, US1502000428, US1517000656, US1450000326, US1324000048, US1231000017, US1502000444 US1107010018 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, US1652000035 US1652000063, 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, US1517000715 US1517000716 ,US1517000738, US1518000744, US1518000773, US1518000774, US1518000775, US1438000110, US1419000026, US1441000162, US1502000388, US1517000679,  US1202010218, US1202010221, US1202010222, US1202010223, US1202010228, US1202010230, US1202010232, US1202010240, US1202010244, US1202010246, US1202010249, US1203010293, US1203010297, US1203010309, US1203010311, US1203010323, US1203010327, US1203010328, US1203010339, US1239000044, US1251000046, US1311000003, US1231000004, US1319000009, US1638002566, US1638002599, US1244000027, US1109010080, US1231000075, US1234000012, US1234000037, US1234000064, US1238000008, US1238000010, US1239000020, US1239000031, US1239000033, US1239000038, US1244000006, US1244000050, US1202010194, US1202010245, US1331000044, US1328000013, US1331000021, US1251000084, US1248000052, US1331000049, US1331000068, US1334000004, US1224000047, US1234000080, US1251000039, US1251000043, US1251000045, US1251000048, US1251000049, US1251000060, US1251000062, US1251000068, US1224000023, US1107010028, US1107010029, US1107010039, US1107010032, US1550001453, US1638002623, US1644002626, US1644002628, US1644002630, US1511000649, US1625002268, US1625002273, US1625002278, US1625002286, US1234000070, US1708000120, US1709000273, US1239000030, US1239000049, US1324000031, US1324000044, US1502000439, US1443000183, US1550001480, US1202010215, US1231000019, US1251000089, US1534001245, US1251000022, US132000007, US132000019, US1203010397, US1238000002, US1238000003, US1523000881,  US1523000854, US1523000855, US1523000866, US1523000893, US1431000005, US1431000011, US1431000014, US1431000026, US1617002002, US1617002003, US1617002010, US1617002025, US1617002028, US1617002045, US1231000071, US1239000028, US1724000489, US1248000063, US1525000907, US1505000517, US1724000506, US1724000512, US1724000517, US1724000539, US1724000552, US1311000081, US1319000014, US1319000018, US1319000095, US1324000040, US1502000470, US1525000915, US1525000924, US1525000927, US1525000933, US1525000935, US1525000945, US1525000952, US1251000025, US1505000490, US1720000458, US1724000466, US1724000474, US1724000487, US1724000495, US1724000496, US1724000501, US1724000507, US1619002099, US1623002117, US1624002199, US1224000035, US1201010128, US1720000448, and US1224000013

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2115-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2115-2018Class IIOngoingVoluntary: Firm initiated