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U.S. Department of Health and Human Services

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

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 Class 2 Recall
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators
see related information
Date Posted December 19, 2012
Recall Status1 Terminated on July 11, 2013
Recall Number Z-0565-2013
Recall Event ID 63714
Premarket Notification
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, FOCU-000651, FOCU-000652, FOCU-000653, FOCU-000654, FOCU-000655, FOCU-000656, FOCU-000657, FOCU-000658, FOCU-000659, FOCU-000660, FOCU-000661, FOCU-000662, FOCU-000663, FOCU-000664, FOCU-000665, FOCU-000666, FOCU-000667, FOCU-000668, FOCU-000669, FOCU-000670, FOCU-000671, FOCU-000672, FOCU-000673, FOCU-000674, FOCU-000675, FOCU-000676, FOCU-000677, FOCU-000678, FOCU-000679, FOCU-000680, focu-000681, focu-000682, focu-000683, focu-000684, focu-000685, focu-000686, focu-000687, focu-000688, focu-000689, focu-000690, FOCU-000691, FOCU-000692, FOCU-000693, FOCU-000694, FOCU-000695, FOCU-000696, focu-000697, FOCU-000698, FOCU-000699, FOCU-000700, FOCU-000701, FOCU-000702, FOCU-000703, FOCU-000704, FOCU-000705, FOCU-000706, FOCU-000707, FOCU-000708, FOCU-000709, FOCU-000710, FOCU-000711, FOCU-000712, FOCU-000713, FOCU-000714, FOCU-000715, FOCU-000716, FOCU-000717, FOCU-000718, FOCU-000719, FOCU-000720, FOCU-000721, FOCU-000722, FOCU-000723, FOCU-000724, FOCU-000725, FOCU-000726, FOCU-000727, FOCU-000728, FOCU-000729, focu-000730, focu-000731, focu-000732, FOCU-000733, FOCU-000734, FOCU-000735, FOCU-000736, FOCU-000737, focu-000738, FOCU-000739, focu-000740, FOCU-000741, FOCU-000742, FOCU-000743, FOCU-000750, FOCU-000751, FOCU-000754, FOCU-000755, focu-000756, focu-000757, focu-000758, focu-000759, focu-000760, focu-000761, FOCU-000762, FOCU-000763, FOCU-000764, FOCU-000765, FOCU-000766, FOCU-000767, FOCU-000768, FOCU-000769, FOCU-000770, FOCU-000771, FOCU-000772, FOCU-000773, FOCU-000774, FOCU-000775, FOCU-000776, FOCU-000777, FOCU-000778, FOCU-000779, FOCU-000780, FOCU-000781, FOCU-000782, FOCU-000783, FOCU-000784, FOCU-000785, focu-000786, FOCU-000787, FOCU-000788, FOCU-000789, FOCU-000790, FOCU-000791, FOCU-000792, FOCU-000793, FOCU-000794, FOCU-000795, focu-000796, FOCU-000797, FOCU-000798, FOCU-000799, FOCU-000800, FOCU-000801, FOCU-000802, FOCU-000803, FOCU-000804, focu-000805, FOCU-000806, FOCU-000807, FOCU-000808, focu-000809, FOCU-000812, focu-000813, focu-000814, FOCU-000815, FOCU-000816, FOCU-000817, FOCU-000818, focu-000819, focu-000820, focu-000821, focu-000822, focu-000823, focu-000824, focu-000825, focu-000826, focu-000827, focu-000828, focu-000829, focu-000830, focu-000831, focu-000832, focu-000833, focu-000834, focu-000835, focu-000836, focu-000837, focu-000838, focu-000839, focu-000840, FOCU-000841, FOCU-000842, FOCU-000843, FOCU-000844, FOCU-000845, FOCU-000846, FOCU-000847, FOCU-000848, FOCU-000849, FOCU-000850, FOCU-000853, FOCU-000854, focu-00767, focu-00768, FOCU-100001, FOCU-100001, FOCU-100002, focu-100003, FOCU-100004, focu-100005, focu-100006, focu-100007, focu-100008, focu-100009, focu-100016, focu-100017, focu-100018, focu-100019, focu-100020, focu-100021, focu-100022, focu-100023, focu-100024, focu-100025, focu-100026, focu-100027, focu-100028, focu-100031, focu-100032, focu-100033, focu-100034, focu-100035, focu-100036, focu-100037, focu-100038, focu-100039, FOCU-100040, FOCU-100041, FOCU-100042, FOCU-100043, FOCU-100044, 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, FOCU-100137, FOCU-100138, FOCU-100139, FOCU-100140, FOCU-100141, FOCU-100142, FOCU-100143, FOCU-100144, FOCU-100145, FOCU-100146, FOCU-100147, FOCU-100148, FOCU-100149, FOCU-100150, FOCU-100151, FOCU-100152, FOCU-100153, FOCU-100154, FOCU-100155, FOCU-100156, focu-100157, focu-100158, focu-100159, focu-100160, focu-100161, focu-100162, focu-100163, FOCU-100164, FOCU-100165, focu-100179, focu-100180, focu-100181, focu-100182, focu-100183, focu-100184, focu-100185, focu-100186, focu-100187, focu-100188, focu-100189, focu-100190, focu-100191, focu-100192, FOCU-100193, FOCU-100194, FOCU-100195, FOCU-100196, FOCU-100197, FOCU-100198, FOCU-100199, FOCU-100200, FOCU-100201, FOCU-100202, FOCU-100203, FOCU-100204, FOCU-100205, FOCU-100206, FOCU-100207, FOCU-100208, FOCU-100209, FOCU-100210, FOCU-100211, focu-100212, focu-100213, focu-100214, focu-100215, focu-100216, focu-100217, FOCU-100218, FOCU-100219, focu-100220, focu-100221, focu-100222, focu-100223, focu-100224, focu-100225, focu-100226, FOCU-100227, FOCU-100228, FOCU-100229, FOCU-100230, FOCU-100231, focu-100232, focu-100233, focu-100234, focu-100235, focu-100236, FOCU-100237, FOCU-100238, FOCU-100239, FOCU-100240, FOCU-100241, FOCU-100242, FOCU-100243, focu-100244, FOCU-100245, FOCU-100246, FOCU-100247, FOCU-100248, FOCU-100249, FOCU-100250, FOCU-100251, FOCU-100252, FOCU-100253, FOCU-100254, FOCU-100255, FOCU-100256, FOCU-100257, FOCU-100258, FOCU-100259, FOCU-100260, FOCU-100261, FOCU-100262, FOCU-100263, FOCU-100264, FOCU-100265, FOCU-100266, FOCU-100267, FOCU-100268, FOCU-100269, FOCU-100270, FOCU-100271, FOCU-100272, FOCU-100273, FOCU-100274, FOCU-100275, focu-100276, focu-100277, focu-100278, focu-100279, focu-100280, focu-100281, focu-100282, focu-100283, focu-100284, focu-100285, FOCU-100286, FOCU-100287, focu-100288, focu-100289, focu-100290, FOCU-100291, FOCU-100292, focu-100293, focu-100294, focu-100295, focu-100296, focu-100297, focu-100298, focu-100299, focu-100300, focu-100301, focu-100302, focu-100303, focu-100304, focu-100305, focu-100306, focu-100307, focu-100308, focu-100309, focu-100310, focu-100311, focu-100312, focu-100313, focu-100314, focu-100315, FOCU-100316, FOCU-100317, FOCU-100318, FOCU-100319, focu-100320, focu-100321, focu-100322, focu-100323, focu-100324, focu-100325, focu-100326, focu-100327, focu-100328, focu-100329, FOCU-100330, focu-100331, focu-100332, focu-100333, focu-100334, focu-100335, focu-100336, focu-100337, focu-100338, focu-100339, focu-100340, focu-100341, focu-100342, focu-100343, focu-100344, focu-100345, focu-100346, focu-100347, focu-100348, FOCU-100349, focu-100350, focu-100351, focu-100352, focu-100353, focu-100354, focu-100355, focu-100356, focu-100357, focu-100358, focu-100359, focu-100360, focu-100361, focu-100362, focu-100363, focu-100364, focu-100365, focu-100366, focu-100367, focu-100368, focu-100369, focu-100370, focu-100371, focu-100372, focu-100373, focu-100374, focu-100375, focu-100376, focu-100377, focu-100378, focu-100379, focu-100380, focu-100381, focu-100382, focu-100383, focu-100384, focu-100385, focu-100386, focu-100387, focu-100388, focu-100389, focu-100390, focu-100391, focu-100392, focu-100393, focu-100394, focu-100395, focu-100396, focu-100397, focu-100398, focu-100399, focu-100400, focu-100401, focu-100402, focu-100403, focu-100404, focu-100405, focu-100406, focu-100407, focu-100408, focu-100409, focu-100410, focu-100411, FOCU-100412, FOCU-100413, FOCU-100414, FOCU-100415, FOCU-100416, FOCU-100417, FOCU-100418, FOCU-100419, focu-100420, focu-100421, focu-100422, focu-100423, focu-100424, focu-100425, focu-100426, focu-100427, focu-100428, focu-100429, focu-100430, focu-100431, focu-100432, focu-100433, focu-100434, focu-100435, focu-100436, focu-100437, focu-100438, focu-100439, focu-100440, focu-100441, focu-100442, focu-100443, focu-100444, focu-100445, focu-100446, focu-100447, focu-100448, focu-100449, focu-100450, focu-100451, focu-100452, focu-100453, focu-100454, focu-100455, focu-100456, focu-100457, focu-100458, focu-100459, focu-100460, focu-100461, focu-100462, focu-100463, focu-100464, focu-100465, focu-100466, focu-100467, focu-100468, focu-100469, focu-100470, focu-100471, focu-100472, focu-100473, FOCU-100474, focu-100475, focu-100476, focu-100477, focu-100478, focu-100479, focu-100480, focu-100481, focu-100482, focu-100483, focu-100484, focu-100485, focu-100486, focu-100487, focu-100488, focu-100489, focu-100490, focu-100491, focu-100492, focu-100493, focu-100494, focu-100495, focu-100496, focu-100497, focu-100498, focu-100499, focu-100500, focu-100501, focu-100502, focu-100503, focu-100504, focu-100505, focu-100506, focu-100507, focu-100508, focu-100509, focu-100510, focu-100511, focu-100512, focu-100513, FOCU-100514, focu-100515, focu-100516, focu-100517, focu-100518, focu-100519, focu-100520, focu-100521, focu-100522, focu-100523, focu-100524, focu-100525, focu-100526, focu-100527, focu-100528, focu-100529, focu-100530, focu-100531, focu-100532, focu-100533, focu-100534, FOCU-100535, FOCU-100536, FOCU-100537, FOCU-100538, FOCU-100539, FOCU-100540, FOCU-100541, FOCU-100542, FOCU-100543, FOCU-100544, FOCU-100545, FOCU-100546, FOCU-100547, FOCU-100548, FOCU-100549, FOCU-100550, FOCU-100551, FOCU-100552, focu-100553, focu-100554, focu-100555, focu-100556, focu-100557, focu-100558, focu-100559, focu-100560, focu-100561, focu-100562, focu-100563, focu-100564, focu-100565, focu-100566, focu-100567, focu-100568, focu-100569, focu-100570, focu-100571, focu-100572, focu-100573, focu-100574, focu-100575, focu-100576, focu-100577, focu-100578, focu-100579, focu-100580, focu-100581, focu-100582, focu-100583, focu-100584, focu-100585, focu-100586, focu-100587, focu-100588, focu-100589, focu-100590, focu-100591, focu-100592, focu-100593, focu-100594, focu-100595, focu-100596, focu-100597, FOCU-100598, FOCU-100599, FOCU-100600, FOCU-100601, FOCU-100602, FOCU-100603, focu-100604, focu-100605, focu-100606, focu-100607, focu-100608, focu-100609, focu-100610, focu-100611, 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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
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 2
PRODUCTION CONTROLS: Error in Labeling
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 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 = BSZ and Original Applicant = BLEASE MEDICAL EQUIPMENT LTD.
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