Class 2 Device Recall BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators

• Date Initiated by Firm: November 02, 2012
• Date Posted: December 19, 2012
• Recall Status: Terminated on July 11, 2013
• Recall Number: Z-0565-2013
• Recall Event ID: 63714
• 510(K)Number: K003251
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine.; ; In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.
• Code Information: Serial numbers for three workstations in the US: focu-101917; focu-101909; and focu-101881. Serial numbers for BleaseFocus workstations in other countries: FOCO-100076, FOCO-100077, FOCO-100078, FOCO-100079, FOCO-100080, FOCO-100081, FOCU-000353, FOCU-000354, FOCU-000355, FOCU-000356, FOCU-000357, FOCU-000364, FOCU-000365, FOCU-000405, FOCU-000406, FOCU-000407, FOCU-000408, FOCU-000409, FOCU-000410, FOCU-000411, FOCU-000412, FOCU-000413, FOCU-000414, FOCU-000415, FOCU-000416, FOCU-000417, FOCU-000418, FOCU-000419, FOCU-000420, FOCU-000421, FOCU-000422, FOCU-000423, FOCU-000424, FOCU-000425, focu-000454, FOCU-000455, FOCU-000456, FOCU-000457, FOCU-000458, FOCU-000459, FOCU-000460, FOCU-000461, FOCU-000462, FOCU-000463, focu-000464, FOCU-000465, FOCU-000466, FOCU-000467, FOCU-000468, FOCU-000469, FOCU-000470, FOCU-000471, FOCU-000472, FOCU-000473, FOCU-000474, FOCU-000475, FOCU-000476, FOCU-000477, FOCU-000478, FOCU-000479, FOCU-000480, FOCU-000481, FOCU-000482, FOCU-000483, FOCU-000484, FOCU-000485, FOCU-000486, FOCU-000487, FOCU-000488, FOCU-000489, FOCU-000490, FOCU-000491, FOCU-000492, FOCU-000493, FOCU-000494, FOCU-000495, FOCU-000496, FOCU-000497, FOCU-000498, FOCU-000499, FOCU-000500, FOCU-000501, FOCU-000502, FOCU-000503, FOCU-000504, FOCU-000505, FOCU-000506, FOCU-000507, FOCU-000508, FOCU-000509, FOCU-000510, FOCU-000511, FOCU-000512, FOCU-000513, FOCU-000514, FOCU-000515, FOCU-000516, FOCU-000517, FOCU-000518, FOCU-000519, FOCU-000520, FOCU-000521, FOCU-000522, FOCU-000523, FOCU-000524, FOCU-000525, FOCU-000526, FOCU-000527, FOCU-000528, FOCU-000529, FOCU-000530, FOCU-000531, FOCU-000532, FOCU-000533, FOCU-000534, FOCU-000535, FOCU-000536, FOCU-000537, FOCU-000538, FOCU-000539, FOCU-000540, FOCU-000541, FOCU-000542, FOCU-000543, FOCU-000544, FOCU-000545, FOCU-000546, FOCU-000547, FOCU-000548, FOCU-000549, FOCU-000550, FOCU-000551, FOCU-000552, FOCU-000553, FOCU-000554, FOCU-000555, FOCU-000556, FOCU-000557, FOCU-000558, FOCU-000562, FOCU-000565, FOCU-000566, FOCU-000567, FOCU-000568, FOCU-000569, FOCU-000570, FOCU-000571, FOCU-000572, FOCU-000573, FOCU-000574, FOCU-000575, FOCU-000576, FOCU-000577, FOCU-000578, focu-000579, focu-000580, FOCU-000581, FOCU-000582, FOCU-000583, FOCU-000584, FOCU-000585, FOCU-000586, FOCU-000587, FOCU-000588, FOCU-000589, FOCU-000590, FOCU-000591, FOCU-000592, FOCU-000593, FOCU-000594, FOCU-000595, FOCU-000596, FOCU-000597, FOCU-000598, FOCU-000599, FOCU-000600, FOCU-000601, FOCU-000602, FOCU-000603, FOCU-000604, FOCU-000605, FOCU-000606, FOCU-000607, FOCU-000608, FOCU-000609, FOCU-000610, FOCU-000611, FOCU-000612, FOCU-000613, FOCU-000614, FOCU-000615, FOCU-000616, FOCU-000617, FOCU-000618, FOCU-000619, FOCU-000620, FOCU-000621, FOCU-000622, FOCU-000623, focu-000624, FOCU-000625, focu-000626, FOCU-000627, FOCU-000628, FOCU-000629, FOCU-000630, FOCU-000631, FOCU-000632, FOCU-000633, FOCU-000634, FOCU-000635, FOCU-000636, FOCU-000637, FOCU-000638, FOCU-000639, FOCU-000640, FOCU-000641, FOCU-000642, FOCU-000643, FOCU-000644, focu-000645, focu-000646, FOCU-000647, focu-000648, focu-000649, FOCU-000650, 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FOCU-100045, FOCU-100046, FOCU-100047, FOCU-100048, FOCU-100049, FOCU-100050, FOCU-100051, FOCU-100052, focu-100053, focu-100054, focu-100055, focu-100056, FOCU-100057, FOCU-100058, FOCU-100059, FOCU-100060, focu-100069, focu-100070, focu-100071, focu-100072, focu-100073, focu-100074, focu-100075, focu-100082, focu-100083, focu-100084, FOCU-100085, FOCU-100087, FOCU-100088, FOCU-100089, FOCU-100090, FOCU-100091, FOCU-100092, FOCU-100093, FOCU-100094, FOCU-100095, FOCU-100096, FOCU-100097, FOCU-100098, focu-100099, focu-100100, focu-100101, focu-100102, focu-100103, focu-100104, focu-100105, focu-100106, focu-100107, focu-100108, focu-100109, focu-100110, FOCU-100111, focu-100112, FOCU-100113, focu-100114, FOCU-100115, FOCU-100116, FOCU-100117, FOCU-100118, FOCU-100119, FOCU-100120, FOCU-100121, FOCU-100122, FOCU-100123, FOCU-100124, FOCU-100125, FOCU-100126, FOCU-100127, FOCU-100128, FOCU-100129, FOCU-100130, FOCU-100131, FOCU-100132, FOCU-100133, FOCU-100134, FOCU-100135, FOCU-100136, 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FOCU-101751, FOCU-101752, FOCU-101753, FOCU-101754, FOCU-101755, FOCU-101756, FOCU-101757, FOCU-101758, FOCU-101759, FOCU-101760, FOCU-101761, FOCU-101762, FOCU-101763, FOCU-101764, FOCU-101765, FOCU-101766, FOCU-101767, FOCU-101768, FOCU-101769, FOCU-101770, FOCU-101771, FOCU-101772, FOCU-101773, FOCU-101774, FOCU-101775, FOCU-101776, FOCU-101777, FOCU-101778, focu-101779, FOCU-101780, FOCU-101781, FOCU-101782, FOCU-101783, FOCU-101784, FOCU-101785, FOCU-101786, FOCU-101787, FOCU-101788, FOCU-101789, FOCU-101790, FOCU-101791, FOCU-101792, FOCU-101793, FOCU-101794, FOCU-101800, FOCU-101801, FOCU-101802, FOCU-101803, FOCU-101804, FOCU-101805, FOCU-101806, FOCU-101807, FOCU-101808, FOCU-101809, FOCU-101810, focu-101811, focu-101812, focu-101813, FOCU-101814, FOCU-101815, FOCU-101816, FOCU-101817, FOCU-101818, FOCU-101819, FOCU-101820, focu-101821, focu-101822, focu-101823, FOCU-101827, FOCU-101828, FOCU-101829, FOCU-101830, focu-101831, focu-101832, focu-101833, focu-101834, focu-101835, focu-101836, focu-101837, focu-101838, focu-101839, focu-101840, focu-101841, FOCU-101842, FOCU-101843, FOCU-101844, focu-101845, FOCU-101846, FOCU-101847, FOCU-101848, FOCU-101849, FOCU-101850, FOCU-101851, FOCU-101852, FOCU-101853, FOCU-101854, FOCU-101855, FOCU-101856, FOCU-101857, FOCU-101858, FOCU-101859, FOCU-101860, focu-101861, focu-101862, focu-101863, focu-101864, focu-101865, FOCU-101866, FOCU-101867, FOCU-101868, FOCU-101869, FOCU-101870, FOCU-101871, FOCU-101872, FOCU-101873, FOCU-101874, FOCU-101875, FOCU-101876, FOCU-101877, FOCU-101878, FOCU-101879, FOCU-101880, FOCU-101882, FOCU-101883, FOCU-101884, FOCU-101885, FOCU-101886, FOCU-101887, FOCU-101888, FOCU-101889, FOCU-101890, focu-101891, focu-101892, focu-101893, focu-101894, focu-101895, focu-101896, focu-101897, FOCU-101898, FOCU-101899, FOCU-101900, FOCU-101901, FOCU-101902, FOCU-101903, FOCU-101904, FOCU-101905, FOCU-101906, FOCU-101907, FOCU-101908, FOCU-101910, FOCU-101911, FOCU-101912, FOCU-101913, FOCU-101914, FOCU-101915, focu-101926, focu-101927, FUCU-000426, FUCU-000427, FUCU-000428, FUCU-000429, FUCU-000430, FUCU-000431, FUCU-000432, FUCU-000433, FUCU-000434, FUCU-000435, FUCU-000436, FUCU-000437, FUCU-000438, FUCU-000439, FUCU-000440, FUCU-000441, FUCU-000442, FUCU-000443, FUCU-000444, FUCU-000445, FUCU-000446, FUCU-000447, FUCU-000448, FUCU-000449, FUCU-000450, FUCU-000451, FUCU-000452, FUCU-000453, FUCU-000744, FUCU-000745, FUCU-000746, FUCU-000747, FUCU-000748, FUCU-000749, FUCU-100166, FUCU-100167, FUCU-100168, FUCU-100169, FUCU-100170, FUCU-100171, FUCU-100172, FUCU-100173, FUCU-100174, FUCU-100175, FUCU-100176, FUCU-100177, and FUCU-100178. Serial numbers for the ventilators in other countries: VENT-001034, VENT-001036, VENT-001037, VENT-001038, VENT-001039, VENT-001040, VENT-001041, VENT-001042, VENT-001043, VENT-001044, VENT-001045, VENT-001046, VENT-001048, VENT-001049, VENT-001050, VENT-001051, VENT-001052, VENT-001053, VENT-001054, VENT-001055, VENT-001056, VENT-001057, VENT-001058, VENT-001059, VENT-001060, VENT-001061, VENT-001062, VENT-001063, VENT-001064, VENT-001065, VENT-001067, VENT-001069, VENT-001070, VENT-001071, VENT-001072, VENT-001073, VENT-001074, VENT-001075, VENT-001077, VENT-001078, VENT-001080, VENT-001082, VENT-001083, VENT-001084, VENT-001085, VENT-001086, VENT-001087, VENT-001089, VENT-001090, VENT-001096, VENT-001097, VENT-001098, VENT-001113, VENT-001114, VENT-001171, VENT-001172, VENT-001173, VENT-001174, VENT-001175, VENT-001176, VENT-001177, vent-001179, vent-001180, vent-001181, vent-001182, vent-001183, vent-001202, vent-001203, VENT-001286, VENT-001288, VENT-001289, VENT-001290, VENT-001321, VENT-001322, VENT-001323, VENT-001324, VENT-001336, vent-001339, VENT-001340, vent-001341, VENT-001342, VENT-001346, VENT-001456, vent-001458, VENT-001469, VENT-001550, VENT-001552, VENT-001557, VENT-001558, VENT-001559, VENT-001560, VENT-001567, VENT-001568, VENT-001569, VENT-001570, VENT-001571, VENT-001572, VENT-001620, VENT-001753, vent-001856, vent-001875, VENT-001889, VENT-001893, VENT-001896, VENT-001898, VENT-001933, VENT-001934, VENT-001935, VENT-001937, VENT-001938, VENT-001939, VENT-001940, VENT-001941, VENT-001955, VENT-001958, VENT-001959, vent-001966, VENT-001978, vent-001979, VENT-001981, vent-001983, VENT-001984, VENT-001989, VENT-001993, VENT-001994, VENT-001996, VENT-001997, VENT-001998, VENT-001999, VENT-002002, VENT-002004, VENT-002005, VENT-002006, VENT-002007, VENT-002009, VENT-002010, VENT-002011, VENT-002012, VENT-002013, VENT-002014, VENT-002015, VENT-002016, VENT-002017, VENT-002019, VENT-002020, VENT-002022, VENT-002023, VENT-002024, VENT-002026, VENT-002031, VENT-002033, VENT-002034, VENT-002036, VENT-002037, VENT-002038, VENT-002039, VENT-002040, VENT-002042, VENT-002046, VENT-002052, VENT-002068, VENT-002071, VENT-002107, VENT-002110, VENT-002111, VENT-002112, VENT-002113, VENT-002114, VENT-002116, VENT-002117, VENT-002119, VENT-002123, VENT-002124, VENT-002125, VENT-002126, VENT-002127, VENT-002128, VENT-002129, VENT-002130, VENT-002131, VENT-002132, VENT-002133, VENT-002136, VENT-002137, VENT-002138, VENT-002140, VENT-002141, VENT-002142, VENT-002143, VENT-002144, VENT-002145, VENT-002146, VENT-002151, VENT-002152, VENT-002153, VENT-002154, VENT-002155, VENT-002157, VENT-002163, VENT-002167, VENT-002170, VENT-002172, VENT-002173, VENT-002174, vent-002175, vent-002179, vent-002180, vent-002181, vent-002182, vent-002183, vent-002184, vent-002187, vent-002189, vent-002190, vent-002191, vent-002192, vent-002193, vent-002194, vent-002195, vent-002196, vent-002197, vent-002198, vent-002199, vent-002200, vent-002217, vent-002218, vent-002260, vent-002261, vent-002262, vent-002263, vent-002264, vent-002265, vent-002266, vent-002267, vent-002268, vent-002269, vent-002279, vent-002280, vent-002281, vent-002282, vent-002283, vent-002284, vent-002285, vent-002286, vent-002287, vent-002288, vent-002289, VENT-002328, VENT-002330, VENT-002331, VENT-002341, vent-002351, vent-002355, VENT-002358, vent-002431, vent-002432, vent-002438, vent-002440, vent-002441, vent-002442, vent-002443, vent-002444, vent-002445, vent-002446, vent-002448, VENT-002452, VENT-002453, VENT-002454, VENT-002455, VENT-002458, VENT-002459, VENT-002460, VENT-002461, vent-002462, VENT-002463, VENT-002465, VENT-002466, VENT-002468, vent-002469, vent-002470, VENT-002471, vent-002472, vent-002473, vent-002474, vent-002476, vent-002478, vent-002479, vent-002482, vent-002484, vent-002485, vent-002486, vent-002487, vent-002488, vent-002489, vent-002490, vent-002492, vent-002493, vent-002494, vent-002495, vent-002496, vent-002497, vent-002498, vent-002499, vent-002500, VENT-002501, vent-002502, VENT-002505, VENT-002506, VENT-002508, VENT-002509, VENT-002510, VENT-002511, VENT-002512, VENT-002513, VENT-002514, VENT-002516, VENT-002518, VENT-002519, VENT-002520, VENT-002526, VENT-002527, VENT-002528, VENT-002530, VENT-002531, VENT-002532, VENT-002535, VENT-002536, VENT-002538, VENT-002541, VENT-002542, VENT-002545, vent-002546, vent-002547, VENT-002550, VENT-002551, VENT-002552, VENT-002554, VENT-002555, VENT-002556, VENT-002568, VENT-002569, VENT-002570, VENT-002571, VENT-002572, VENT-002573, VENT-002574, VENT-002575, VENT-002578, VENT-002579, VENT-002585, VENT-002586, vent-002595, vent-002601, VENT-002602, vent-002603, VENT-002604, VENT-002605, VENT-002607, VENT-002608, VENT-002609, VENT-002610, VENT-002611, VENT-002667, VENT-002670, VENT-002671, VENT-002672, VENT-002673, VENT-002674, VENT-002675, VENT-002676, VENT-002679, VENT-002680, VENT-002681, VENT-002682, VENT-002683, VENT-002684, VENT-002688, VENT-002689, VENT-002694, VENT-002695, VENT-002696, VENT-002708, VENT-002711, VENT-002712, VENT-002713, VENT-002714, VENT-002715, VENT-002716, VENT-002717, VENT-002718, VENT-002719, VENT-002720, VENT-002721, VENT-002722, VENT-002724, VENT-002725, VENT-002726, VENT-002729, VENT-002730, VENT-002732, VENT-002733, VENT-002734, VENT-002735, VENT-002736, VENT-002737, VENT-002739, VENT-002740, VENT-002741, VENT-002742, VENT-002743, VENT-002744, vent-002745, VENT-002746, vent-002747, VENT-002748, vent-002749, vent-002750, vent-002751, vent-002752, vent-002753, vent-002754, vent-002755, vent-002756, VENT-002757, vent-002758, vent-002759, vent-002760, VENT-002761, VENT-002762, VENT-002763, VENT-002764, VENT-002765, VENT-002766, VENT-002767, VENT-002768, VENT-002769, VENT-002770, VENT-002771, VENT-002772, VENT-002773, VENT-002774, VENT-002775, VENT-002776, VENT-002777, VENT-002779, VENT-002780, VENT-002783, VENT-002784, VENT-002785, VENT-002786, VENT-002787, VENT-002788, VENT-002789, VENT-002790, VENT-002791, VENT-002793, VENT-002794, VENT-002795, VENT-002796, VENT-002798, VENT-002799, VENT-002800, vent-002801, vent-002832, vent-002857, vent-002868, vent-002873, vent-002896, vent-002909, vent-002916, vent-003005, vent-003006, vent-003007, vent-003008, vent-003009, vent-003010, VENT-003016, vent-003069, vent-003140, vent-003141, vent-003142, vent-003148, vent-003149, vent-003150, vent-003151, vent-003153, vent-003154, vent-003155, vent-003195, vent-003202, vent-003203, vent-003204, vent-003205, vent-003206, vent-003207, vent-003208, vent-003209, vent-003210, vent-003211, vent-003212, vent-003215, vent-003219, vent-003222, vent-003223, vent-003224, vent-003240, vent-003241, vent-003272, vent-003278, vent-003280, vent-003281, vent-003282, vent-003283, vent-003290, vent-003324, vent-003331, vent-003343, vent-003344, vent-003346, vent-003348, vent-003351, vent-003358, vent-003448, vent-003619, vent-003630, vent-003631, vent-003632, vent-003634, vent-003664, vent-003670, vent-003671, vent-003672, vent-003673, vent-003675, vent-003676, vent-003678, vent-003679, vent-003680, vent-003681, vent-003682, vent-003683, vent-003684, vent-003685, vent-003686, vent-003687, vent-003688, vent-003691, vent-003692, vent-003693, vent-003697, vent-003699, vent-003704, vent-003706, vent-003719, vent-003722, vent-003723, vent-003727, vent-003728, vent-003729, vent-003876, vent-003882, vent-003884, vent-003885, vent-004025, vent-004036, vent-004172, vent-004179, vent-004200, vent-004203, vent-004204, vent-004206, vent-004225, vent-004229, vent-004230, vent-004238, vent-004243, vent-004275, vent-004276, vent-004277, vent-004278, vent-004279, vent-004281, vent-004282, vent-004283, vent-004284, vent-004285, vent-004286, vent-004287, vent-004288, vent-004291, vent-004295, vent-004297, vent-004298, vent-004301, vent-004303, vent-004304, vent-004306, vent-004307, vent-004308, vent-004310, vent-004311, vent-004313, vent-004314, vent-004315, vent-004316, vent-004317, vent-004318, vent-004319, vent-004320, vent-004321, vent-004322, vent-004323, vent-004324, vent-004325, vent-004326, vent-004327, vent-004328, vent-004329, vent-004330, vent-004331, vent-004332, vent-004333, vent-004334, vent-004335, vent-004337, vent-004342, vent-004611, vent-004612, vent-004613, vent-004616, vent-004617, vent-004619, vent-004620, vent-004762, vent-004767, vent-004770, vent-004771, vent-004773, vent-004776, vent-004779, vent-004786, vent-004787, vent-004790, vent-004794, vent-004798, vent-004800, vent-004801, vent-004802, vent-004803, vent-004806, vent-004807, vent-004808, vent-004809, vent-004810, vent-004811, vent-004812, vent-004813, vent-004816, vent-004817, vent-004818, vent-004819, vent-004820, vent-004821, vent-004824, vent-004825, vent-004826, vent-004827, vent-004828, vent-004829, vent-004830, vent-004831, vent-004835, vent-004836, vent-004837, vent-004838, vent-004839, vent-004840, vent-004842, vent-004843, vent-004845, vent-004846, vent-004850, vent-004853, vent-004926, vent-004927, vent-004928, vent-004930, vent-004931, vent-004932, vent-004933, vent-004934, vent-004935, vent-004937, vent-004938, vent-004939, vent-004940, vent-004941, vent-004942, vent-004943, vent-004944, vent-004948, vent-004951, vent-004953, vent-004956, vent-004959, vent-004960, vent-004961, vent-004965, vent-004968, vent-004969, vent-004971, vent-004972, vent-004973, vent-004974, vent-004975, vent-004976, VENT-004977, VENT-004978, VENT-004979, VENT-004980, VENT-004981, VENT-004982, VENT-004983, vent-004984, VENT-004985, VENT-004986, VENT-004987, VENT-004988, VENT-004989, VENT-004990, VENT-004991, VENT-004992, VENT-004993, VENT-004994, VENT-004995, VENT-004996, VENT-004999, VENT-005000, VENT-005008, VENT-005009, VENT-005010, VENT-005011, VENT-005012, VENT-005013, VENT-005015, VENT-005017, VENT-005018, VENT-005019, VENT-005020, VENT-005022, VENT-005023, VENT-005025, VENT-005032, VENT-005033, VENT-005034, VENT-005035, VENT-005037, VENT-005039, VENT-005042, VENT-005043, VENT-005044, VENT-005045, VENT-005046, VENT-005047, VENT-005050, VENT-005054, VENT-005057, VENT-005070, VENT-005071, VENT-005072, VENT-005073, VENT-005074, VENT-005075, VENT-005076, VENT-005077, VENT-005078, VENT-005080, VENT-005081, VENT-005082, VENT-005083, VENT-005084, VENT-005086, VENT-005087, VENT-005088, VENT-005104, vent-005107, vent-005108, vent-005109, vent-005110, vent-005111, vent-005112, VENT-005114, VENT-005116, VENT-005118, VENT-005119, VENT-005121, VENT-005122, VENT-005123, VENT-005127, VENT-005129, VENT-005137, VENT-005138, VENT-005139, VENT-005140, VENT-005142, VENT-005143, VENT-005147, VENT-005148, VENT-005149, VENT-005150, VENT-005151, VENT-005152, VENT-005153, VENT-005154, VENT-005155, VENT-005160, VENT-005161, VENT-005165, VENT-005166, VENT-005167, VENT-005168, VENT-005169, VENT-005171, VENT-005179, VENT-005307, VENT-005403, VENT-005407, VENT-005574, VENT-005585, VENT-005586, VENT-005587, VENT-005589, VENT-005590, VENT-005591, vent-005771, vent-005772, vent-005773, vent-005774, vent-005775, VENT-005783, VENT-005784, VENT-005785, VENT-005786.
• Recalling Firm/ Manufacturer: Del Mar Reynolds Medical, Ltd.; 1-2 Harforde Ct., Foxholes; Business Park; Hertford United Kingdom
• For Additional Information Contact: Technical Support; 800-522-7025
• Manufacturer Reason for Recall: The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.
• FDA Determined Cause: Labeling design
• Action: Spacelabs has sent the Urgent -Medical Device Correction-Spacelabs Healthcare BleaseFocus Anesthesia Workstation Blease 700/900 Series Ventilators letter, dated 16 November 2012, to US customers. On November 26, 2012, a customer letter (translated as necessary) was emailed to all international subsidiaries and distributors of record. Customers are advised that the primary alarm will sound only in the event of an O2 supply failure and they will be provided with the corrected user and service manuals that do not reference a secondary O2 supply failure alarm. Customers with questions can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
• Quantity in Commerce: 3 in US and 3121 Outside US
• Distribution: Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BSZ and Original Applicant = BLEASE MEDICAL EQUIPMENT LTD.