• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview SL Command Module/Multiparameter input module

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Ultraview SL Command Module/Multiparameter input module
see related information
Date Posted February 27, 2007
Recall Status1 Open
Recall Number Z-0523-2007
Recall Event ID 37077
Premarket Notification
510(K) Number
K050605 
Product Classification Detector And Alarm, Arrhythmia - Product Code DSI
Product Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
Code Information 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
Recalling Firm/
Manufacturer
Spacelabs Healthcare, Incorporated
5150 220th Ave Se
Issaquah, Washington 98029-6834
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 1347 devices; 1067 domestic and 280 international
Distribution Nationwide and worldwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = SPACELABS MEDICAL INC.
-
-