Events

Rappel de Device Recall Ultraview SL Command Module/Multiparameter input module

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Incorporated.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37077
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0523-2007
  • Date de mise en oeuvre de l'événement
    2007-01-03
  • Date de publication de l'événement
    2007-02-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49866
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    multiparameter patient monitor - Product Code DSI
  • Cause
    Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and sp02 alarm limits being frozen. this can result in delay in treatment.
  • Action
    On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.

Device

Device Recall Ultraview SL Command Module/Multiparameter input module
  • Modèle / numéro de série
    Serial numbers 1496-004112, 1496-005720, 1496-004094, 1496-004088, 1496-004089, 1496-004090, 1496-004091, 1496-004092, 1496-004093, 1496-004110, 1496-011601, 1496-004111, 1496-010974, 1496-010975, 1496-010977, 1496-011021, 1496-004174, 1496-004175, 1496-004177, 1496-004178, 1496-004179, 1496-004180, 1496-004165, 1496-004166, 1496-009201, 1496-006236, 1496-006432, 1496-006434, 1496-008163, 1496-008164, 1496-005413, 1496-011026, 1496-006435, 1496-006436, 1496-006829, 1496-006830, 1496-006831, 1496-006832, 1496-006895, 1496-006912, 1496-006913, 1496-006914, 1496-009137, 1496-009138, 1496-004108, 1496-004109, 1496-005761, 1496-008497, 1496-008498, 1496-008499, 1496-008500, 1496-008501, 1496-010056, 1496-010057, 1496-005369, 1496-005388, 1496-005412, 1496-010607, 1496-010053, 1496-005254, 1496-005255, 1496-005256, 1496-005257, 1496-005258, 1496-005326, 1496-005327, 1496-005328, 1496-005329, 1496-004075, 1496-004076, 1496-004077, 1496-004078, 1496-004079, 1496-004080, 1496-004081, 1496-004082, 1496-004083, 1496-004084, 1496-004085, 1496-004095, 1496-004096, 1496-004097, 1496-004098, 1496-004099, 1496-004100, 1496-004101, 1496-004102, 1496-004103, 1496-004104, 1496-005340, 1496-005361, 1496-005363, 1496-005364, 1496-005365, 1496-010479, 1496-010480, 1496-010482, 1496-010483, 1496-010485, 1496-010486, 1496-010487, 1496-010488, 1496-010489, 1496-010592, 1496-010595, 1496-010602, 1496-010603, 1496-010604, 1496-010605, 1496-010606, 1496-010608, 1496-010609, 1496-010620, 1496-010621, 1496-010623, 1496-010624, 1496-010625, 1496-010627, 1496-010628, 1496-010778, 1496-010819, 1496-010821, 1496-010822, 1496-010823, 1496-010824, 1496-010825, 1496-010826, 1496-010827, 1496-010828, 1496-010829, 1496-010830, 1496-010831, 1496-010832, 1496-010833, 1496-010835, 1496-010836, 1496-010837, 1496-010838, 1496-010839, 1496-010840, 1496-010841, 1496-010842, 1496-010843, 1496-010844, 1496-010845, 1496-010870, 1496-010871, 1496-010872, 1496-010874, 1496-010876, 1496-010877, 1496-010879, 1496-010834, 1496-010846, 1496-010847, 1496-010848, 1496-010849, 1496-010850, 1496-010851, 1496-010852, 1496-010853, 1496-010854, 1496-010855, 1496-010856, 1496-010857, 1496-010858, 1496-010859, 1496-010860, 1496-010861, 1496-010862, 1496-010863, 1496-010864, 1496-010865, 1496-010866, 1496-010867, 1496-010868, 1496-010869, 1496-010094, 1496-010095, 1496-010120, 1496-010121, 1496-010122, 1496-010123, 1496-010124, 1496-010125, 1496-010126, 1496-010127, 1496-010128, 1496-010129, 1496-010130, 1496-010131, 1496-010132, 1496-010133, 1496-010134, 1496-010135, 1496-010136, 1496-010137, 1496-010138, 1496-010466, 1496-010467, 1496-010468, 1496-009114, 1496-009115, 1496-009116, 1496-009117, 1496-009118, 1496-009119, 1496-009120, 1496-009121, 1496-009122, 1496-009123, 1496-009124, 1496-009125, 1496-009126, 1496-009127, 1496-009128, 1496-009129, 1496-009130, 1496-009131, 1496-009132, 1496-009133, 1496-009134, 1496-009143, 1496-009144, 1496-009145, 1496-009146, 1496-009147, 1496-009148, 1496-009149, 1496-009150, 1496-009151, 1496-009152, 1496-009153, 1496-009154, 1496-009155, 1496-009156, 1496-009157, 1496-009158, 1496-009159, 1496-009160, 1496-009161, 1496-009162, 1496-009163, 1496-009164, 1496-009165, 1496-009166, 1496-009167, 1496-009168, 1496-009169, 1496-009170, 1496-009171, 1496-009172, 1496-009173, 1496-009174, 1496-009175, 1496-009176, 1496-009177, 1496-009178, 1496-009179, 1496-009180, 1496-009181, 1496-009182, 1496-009183, 1496-009184, 1496-009186, 1496-009187, 1496-009188, 1496-009189, 1496-009190, 1496-009191, 1496-009192, 1496-009193, 1496-009194, 1496-009195, 1496-009196, 1496-009197, 1496-009198, 1496-009199, 1496-009200, 1496-009207, 1496-009208, 1496-009209, 1496-009210, 1496-009211, 1496-009212, 1496-009213, 1496-009214, 1496-009215, 1496-009216, 1496-009217, 1496-009218, 1496-009219, 1496-009220, 1496-009221, 1496-009222, 1496-009223, 1496-009224, 1496-009225, 1496-009226, 1496-009227, 1496-009228, 1496-009229, 1496-009230, 1496-009231, 1496-009232, 1496-009233, 1496-009234, 1496-009235, 1496-009236, 1496-009237, 1496-009238, 1496-009239, 1496-009240, 1496-009241, 1496-009242, 1496-009243, 1496-009244, 1496-009245, 1496-009246, 1496-009247, 1496-009248, 1496-009249, 1496-009250, 1496-009251, 1496-009252, 1496-009253, 1496-009254, 1496-009255, 1496-009256, 1496-009257, 1496-009258, 1496-009260, 1496-009261, 1496-009262, 1496-009263, 1496-009264, 1496-009908, 1496-009909, 1496-010054, 1496-010055, 1496-010484, 1496-010610, 1496-010611, 1496-010622, 1496-010878, 1496-010880, 1496-010881, 1496-010882, 1496-010883, 1496-010884, 1496-010885, 1496-010886, 1496-010887, 1496-010888, 1496-010889, 1496-010890, 1496-010912, 1496-010970, 1496-010976, 1496-011027, 1496-011440, 1496-011452, 1496-011455, 1496-011459, 1496-011464, 1496-011469, 1496-011470, 1496-011471, 1496-011472, 1496-011473, 1496-011474, 1496-011475, 1496-011476, 1496-011477, 1496-011478, 1496-011479, 1496-011602, 1496-011603, 1496-011604, 1496-011605, 1496-011606, 1496-011607, 1496-011608, 1496-011609, 1496-011610, 1496-011611, 1496-011612, 1496-011613, 1496-011614, 1496-011615, 1496-011616, 1496-011626, 1496-011627, 1496-011628, 1496-011629, 1496-011630, 1496-011631, 1496-011632, 1496-011633, 1496-011634, 1496-011636, 1496-011637, 1496-011638, 1496-011639, 1496-011640, 1496-011641, 1496-009204, 1496-009205, 1496-009206, 1496-007416, 1496-010469, 1496-010470, 1496-010471, 1496-010472, 1496-010473, 1496-010474, 1496-010475, 1496-010476, 1496-010477, 1496-010478, 1496-004807, 1496-004808, 1496-006833, 1496-006896, 1496-006910, 1496-006911, 1496-006915, 1496-006916, 1496-007279, 1496-007280, 1496-007308, 1496-007309, 1496-007310, 1496-007311, 1496-007312, 1496-007313, 1496-007648, 1496-007767, 1496-007768, 1496-007769, 1496-007770, 1496-007771, 1496-007772, 1496-007779, 1496-007780, 1496-007781, 1496-009891, 1496-009892, 1496-009893, 1496-009894, 1496-009895, 1496-009898, 1496-009899, 1496-009900, 1496-005366, 1496-005367, 1496-005368, 1496-005370, 1496-005371, 1496-005372, 1496-005373, 1496-005374, 1496-005375, 1496-005376, 1496-005377, 1496-005378, 1496-005379, 1496-005380, 1496-005381, 1496-005382, 1496-005383, 1496-005384, 1496-005385, 1496-005386, 1496-005387, 1496-006957, 1496-006958, 1496-006967, 1496-006968, 1496-006969, 1496-006970, 1496-006971, 1496-006972, 1496-006973, 1496-006981, 1496-007630, 1496-007631, 1496-007632, 1496-007633, 1496-007744, 1496-007745, 1496-007746, 1496-007747, 1496-007748, 1496-007749, 1496-007750, 1496-007751, 1496-007752, 1496-007753, 1496-007754, 1496-007755, 1496-007756, 1496-007757, 1496-008503, 1496-008504, 1496-008580, 1496-008581, 1496-008582, 1496-008583, 1496-008584, 1496-008585, 1496-008586, 1496-008587, 1496-009847, 1496-009854, 1496-009855, 1496-009856, 1496-009857, 1496-009858, 1496-009859, 1496-009860, 1496-009861, 1496-009862, 1496-009863, 1496-009864, 1496-009865, 1496-009866, 1496-009867, 1496-009868, 1496-009869, 1496-009870, 1496-009871, 1496-009872, 1496-009873, 1496-009874, 1496-009875, 1496-009877, 1496-009878, 1496-009879, 1496-009880, 1496-009882, 1496-009883, 1496-009885, 1496-009886, 1496-009887, 1496-009888, 1496-009889, 1496-009890, 1496-010093, 1496-010891, 1496-010892, 1496-010893, 1496-010894, 1496-010895, 1496-010896, 1496-010898, 1496-010899, 1496-010900, 1496-010901, 1496-010902, 1496-010903, 1496-010904, 1496-010905, 1496-010907, 1496-010909, 1496-010910, 1496-010911, 1496-010913, 1496-010971, 1496-010972, 1496-010973, 1496-009135, 1496-009136, 1496-008636, 1496-008637, 1496-007907, 1496-007908, 1496-007909, 1496-007910, 1496-008166, 1496-008167, 1496-008168, 1496-008495, 1496-008496, 1496-006878, 1496-006879, 1496-006880, 1496-006881, 1496-007859, 1496-007860, 1496-007861, 1496-007862, 1496-004086, 1496-004087, 1496-004124, 1496-004125, 1496-004126, 1496-004127, 1496-004128, 1496-004129, 1496-004130, 1496-004131, 1496-004132, 1496-004133, 1496-004134, 1496-004135, 1496-004136, 1496-004137, 1496-004138, 1496-004139, 1496-004140, 1496-004141, 1496-004142, 1496-004143, 1496-004144, 1496-004145, 1496-004146, 1496-004147, 1496-004148, 1496-004149, 1496-004150, 1496-004151, 1496-004152, 1496-004153, 1496-004154, 1496-004155, 1496-004156, 1496-004157, 1496-004158, 1496-004167, 1496-004168, 1496-004169, 1496-005124, 1496-006543, 1496-009141, 1496-009142, 1496-006876, 1496-006877, 1496-007133, 1496-007140, 1496-007142, 1496-007143, 1496-007145, 1496-007212, 1496-007628, 1496-007629, 1496-008165, 1496-010049, 1496-010050, 1496-004105, 1496-004106, 1496-004107, 1496-004121, 1496-004122, 1496-004123, 1496-004159, 1496-004160, 1496-004161, 1496-004162, 1496-004163, 1496-004164, 1496-004181, 1496-005125, 1496-005126, 1496-005127, 1496-005128, 1496-005129, 1496-005130, 1496-005131, 1496-005132, 1496-005133, 1496-005226, 1496-005227, 1496-005228, 1496-005229, 1496-005230, 1496-005231, 1496-008502, 1496-008588, 1496-008608, 1496-008625, 1496-008626, 1496-008627, 1496-008628, 1496-008629, 1496-008630, 1496-008635, 1496-009259, 1496-009265, 1496-009266, 1496-009267, 1496-009268, 1496-009269, 1496-009270, 1496-009271, 1496-009831, 1496-009832, 1496-009833, 1496-009834, 1496-009835, 1496-009836, 1496-009837, 1496-009838, 1496-009839, 1496-009840, 1496-009841, 1496-009842, 1496-009843, 1496-009844, 1496-009845, 1496-009846, 1496-009848, 1496-009849, 1496-009850, 1496-009851, 1496-009852, 1496-009853, 1496-009881, 1496-009911, 1496-009912, 1496-009913, 1496-009914, 1496-009915, 1496-009916, 1496-009917, 1496-009918, 1496-009919, 1496-009920, 1496-009921, 1496-009922, 1496-004809, 1496-004810, 1496-004811, 1496-004812, 1496-004113, 1496-004114, 1496-004115, 1496-004116, 1496-004804, 1496-005330, 1496-005331, 1496-005332, 1496-005333, 1496-005334, 1496-005335, 1496-005336, 1496-005337, 1496-005338, 1496-005339, 1496-006204, 1496-006205, 1496-006206, 1496-006207, 1496-006208, 1496-006209, 1496-006210, 1496-006211, 1496-006212, 1496-006213, 1496-006214, 1496-006215, 1496-006216, 1496-006217, 1496-006218, 1496-006219, 1496-006220, 1496-006221, 1496-006222, 1496-006223, 1496-006224, 1496-006225, 1496-006226, 1496-006227, 1496-006228, 1496-006229, 1496-006230, 1496-006231, 1496-006232, 1496-006233, 1496-006234, 1496-006235, 1496-006237, 1496-006238, 1496-006239, 1496-006240, 1496-006241, 1496-006882, 1496-006883, 1496-006897, 1496-006898, 1496-006899, 1496-006900, 1496-006906, 1496-006907, 1496-006908, 1496-008638, 1496-008639, 1496-008640, 1496-008641, 1496-008642, 1496-008643, 1496-008644, 1496-008645, 1496-008646, 1496-008647, 1496-008648, 1496-008649, 1496-008650, 1496-008651, 1496-008652, 1496-008653, 1496-008654, 1496-008655, 1496-008656, 1496-008657, 1496-008658, 1496-008659, 1496-008660, 1496-008661, 1496-008662, 1496-008663, 1496-008664, 1496-008665, 1496-009079, 1496-009080, 1496-009081, 1496-009082, 1496-009083, 1496-009084, 1496-009085, 1496-009086, 1496-009087, 1496-009088, 1496-009089, 1496-009090, 1496-009091, 1496-009092, 1496-009093, 1496-009094, 1496-010058, 1496-010059, 1496-010060, 1496-010086, 1496-010087, 1496-010088, 1496-010089, 1496-010090, 1496-010091, 1496-010092, 1496-005414, 1496-005415, 1496-005416, 1496-005702, 1496-005703, 1496-005704, 1496-005705, 1496-005706, 1496-005707, 1496-005708, 1496-005709, 1496-005710, 1496-005711, 1496-005712, 1496-005713, 1496-005714, 1496-005715, 1496-005716, 1496-005717, 1496-005718, 1496-005719, 1496-005721, 1496-005722, 1496-005723, 1496-005724, 1496-005725, 1496-005726, 1496-005727, 1496-005728, 1496-005729, 1496-005730, 1496-005731, 1496-005732, 1496-005733, 1496-005734, 1496-005735, 1496-005736, 1496-005737, 1496-005738, 1496-005739, 1496-005740, 1496-005741, 1496-005742, 1496-005743, 1496-005744, 1496-005745, 1496-005746, 1496-005747, 1496-005748, 1496-005749, 1496-005750, 1496-005751, 1496-005752, 1496-005753, 1496-005754, 1496-005755, 1496-005756, 1496-005757, 1496-005758, 1496-005759, 1496-005760, 1496-005977, 1496-006111, 1496-006112, 1496-006113, 1496-008589, 1496-008590, 1496-008591, 1496-008592, 1496-008593, 1496-008594, 1496-008595, 1496-008596, 1496-008597, 1496-008598, 1496-008599, 1496-008600, 1496-008601, 1496-008602, 1496-008603, 1496-008604, 1496-008605, 1496-008606, 1496-008607, 1496-008609, 1496-008611, 1496-008612, 1496-008613, 1496-008614, 1496-008615, 1496-008616, 1496-008617, 1496-008618, 1496-008619, 1496-008620, 1496-008621, 1496-008622, 1496-008623, 1496-008624, 1496-009095, 1496-009096, 1496-009097, 1496-009098, 1496-009099, 1496-009100, 1496-009101, 1496-009102, 1496-009103, 1496-009104, 1496-009105, 1496-009106, 1496-009107, 1496-009108, 1496-009109, 1496-009110, 1496-009111, 1496-009112, 1496-009113, 1496-009202, 1496-009203, 1496-009884, 1496-010906, 1496-010908, 1496-007411, 1496-007412, 1496-007413, 1496-007414, 1496-007415, 1496-007417, 1496-007461, 1496-007475, 1496-006828, 1496-006885, 1496-006886, 1496-006887, 1496-006888, 1496-006889, 1496-006890, 1496-006891, 1496-006892, 1496-006893, 1496-004117, 1496-004118, 1496-007458, 1496-007459, 1496-007460, 1496-007869, 1496-007870, 1496-007905, 1496-009876, 1496-009901, 1496-009902, 1496-009903, 1496-009904, 1496-009905, 1496-009906, 1496-009907, 1496-009910, 1496-006974, 1496-006975, 1496-006976, 1496-006977, 1496-006978, 1496-006979, 1496-006980, 1496-007123, 1496-007124, 1496-007125, 1496-007126, 1496-007127, 1496-007128, 1496-007129, 1496-007130, 1496-007131, 1496-007134, 1496-007135, 1496-007136, 1496-007138, 1496-007139, 1496-010490, 1496-010491, 1496-010492, 1496-010493, 1496-010494, 1496-010495, 1496-010496, 1496-010513, 1496-010516, 1496-010517, 1496-010518, 1496-010519, 1496-010593, 1496-010594, 1496-010596, 1496-010897, 1496-011022, 1496-011023, 1496-011024, 1496-011025, 1496-005762, 1496-005976, 1496-005978, 1496-005979, 1496-005980, 1496-005982, 1496-005983, 1496-005984, 1496-005985, 1496-005986, 1496-005987, 1496-005988, 1496-005989, 1496-005990, 1496-005991, 1496-005992, 1496-005993, 1496-005994, 1496-005995, 1496-005997, 1496-008129, 1496-008161, 1496-008162, 1496-007906, 1496-008249, 1496-008250, 1496-009139, 1496-009140, 1496-009363, 1496-009364, 1496-009365, 1496-009366, 1496-009185, 1496-004779, 1496-004780, 1496-004781, 1496-004782, 1496-004783, 1496-004784, 1496-004785, 1496-006526, 1496-006527, 1496-006528, 1496-006529, 1496-006530, 1496-006546, 1496-006547, 1496-006548, 1496-006549, 1496-006550, 1496-004176, 1496-005018, 1496-007819, 1496-007820, 1496-007821, 1496-007822, 1496-007823, 1496-007858, 1496-007863, 1496-007864, 1496-007865, 1496-007866, 1496-004170, 1496-004171, 1496-005185, 1496-006433, 1496-006524, 1496-006917, 1496-006918, 1496-006919, 1496-006920, 1496-006921, 1496-006922, 1496-007682, 1496-007696, 1496-008631, 1496-008632, 1496-008633, 1496-008634, 1496-011437, 1496-005014, 1496-005015, 1496-006545, 1496-007213, 1496-007214, 1496-007215, 1496-007216, 1496-007217, 1496-007218, 1496-007219, 1496-007220, 1496-007221, 1496-007222, 1496-007223, 1496-007224, 1496-007225, 1496-007263, 1496-007264, 1496-007265, 1496-007266, 1496-007267, 1496-007269, 1496-007270, 1496-007271, 1496-007272, 1496-007273, 1496-007274, 1496-007275, 1496-007276, 1496-007277, 1496-007278, 1496-007307, 1496-007314, 1496-007315, 1496-007316, 1496-007317, 1496-007410, 1496-007758, 1496-007759, 1496-007760, 1496-007761, 1496-007762, 1496-007763, 1496-007764, 1496-007765, 1496-006821, 1496-006822, 1496-006823, 1496-006824, 1496-006825, 1496-006826, 1496-006827, 1496-006834, 1496-006884, 1496-006894, 1496-006923, 1496-006926, 1496-006927, 1496-006928, 1496-007649, 1496-010051, 1496-010052, 1496-010497, 1496-010498, 1496-010499, 1496-010500, 1496-010501, 1496-010502, 1496-010503, 1496-010504, 1496-010505, 1496-010506, 1496-010507, 1496-010508, 1496-010509, 1496-010510, 1496-010511, 1496-010512, 1496-010514, 1496-010515, 1496-011028, 1496-011029, 1496-011030, 1496-011031, 1496-011032, 1496-011033, 1496-011034, 1496-011035, 1496-011036, 1496-011037, 1496-011038, 1496-011039, 1496-011040, 1496-011041, 1496-011042, 1496-011043, 1496-011044, 1496-011045, 1496-011423, 1496-011424, 1496-011425, 1496-011426, 1496-011427, 1496-011428, 1496-011429, 1496-011430, 1496-011431, 1496-011432, 1496-011433, 1496-011434, 1496-011435, 1496-011436, 1496-011438, 1496-011439, 1496-011441, 1496-011442, 1496-011443, 1496-011444, 1496-011445, 1496-011446, 1496-011447, 1496-011448, 1496-011449, 1496-011450, 1496-011451, 1496-011453, 1496-011454, 1496-011456, 1496-011457, 1496-011458, 1496-011460, 1496-011461, 1496-011462, 1496-011463, 1496-011465, 1496-011466, 1496-011467, 1496-011468, 1496-004805, 1496-004806, 1496-005048, 1496-005049, 1496-005050, 1496-005051, 1496-005052, 1496-005885, 1496-005886, 1496-005887, 1496-005888, 1496-007132, 1496-007137, 1496-007141, 1496-006875, 1496-010626, 1496-010820, 1496-010873, 1496-010875, 1496-007621, 1496-007622, 1496-007623, 1496-007624, 1496-007625, 1496-007626, 1496-007627, 1496-006114, 1496-006115, 1496-004119, 1496-004120, 1496-009896, 1496-009897, 1496-009959, 1496-004183, 1496-004184, 1496-004813, 1496-004814, 1496-004815, 1496-004816, 1496-004817, 1496-004818, 1496-006531, 1496-006532, 1496-006533, 1496-006534, 1496-006535, 1496-006536, 1496-006537, 1496-006538, 1496-006539, 1496-006540, 1496-006541, 1496-006542, 1496-007867, 1496-007868, 1496-009925, 1496-009951, 1496-009952, 1496-010046, 1496-010047, 1496-010048, 1496-010481, 1496-011185, 1496-011186, 1496-011187, 1496-011600, 1496-006116, 1496-006909, 1496-006924, 1496-006925, 1496-006929, 1496-006930, 1496-006931, 1496-006932, 1496-006933, 1496-006934, 1496-006935, 1496-006936, 1496-006937, 1496-006938, 1496-006939, 1496-006940, 1496-006941, 1496-006942, 1496-006943, 1496-006944, 1496-006945, 1496-006946, 1496-006947, 1496-006948, 1496-006949, 1496-006950, 1496-006952, 1496-006953, 1496-006954, 1496-006955, 1496-006956, 1496-009923, 1496-009924
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and worldwide.
  • Description du dispositif
    Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Adresse du fabricant
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA