FDA · Medical device recall

GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems… and 2 more products

March 19, 2014 Class II

Date: March 19, 2014
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N
Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.

3 products in this recall

GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems…

Product: GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Quantity: 3062 units (1182 US, 1880 OUS)
Codes and lots: Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100, 1101, 1101, 1102, 1105, 1106, 1107, 1110, 1111, 1112, 1116, 1118, 1119, 1126, 1132, 1141, 1144, 1145, 1149, 1153, 1155, 1289, 1372, 1505, 1538, 1617, 1629, 1649, 1666, 1693, 1696, 1697, 1704, 1729, 1730, 1756, 1804, 1814, 1831, 1835, 1890, 1998, 1999, 3003, 5004, 5007, 8007, 10023, 10028, 10032, 10040, 10041, 10057, 10103, 10115, 10121, 10124, 10129, 10130, 10133, 10138, 10139, 10143, 10146, 10146, 10150, 10156, 10158, 10164, 10165, 10166, 10167, 10168, 10169, 10171, 10172, 10173, 10175, 10176, 10177, 10178, 10179, 10180, 10180, 10182, 10185, 10187, 10188, 10189, 10190, 10191, 10193, 10194, 10195, 10197, 10199, 10204, 10206, 10207, 10209, 10210, 10211, 10212, 10216, 10217, 10218, 10222, 10224, 10225, 10228, 10229, 10230, 10234, 10235, 10236, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10246, 10249, 10250, 10251, 10253, 10254, 10256, 10260, 10262, 10263, 10264, 10265, 10267, 10268, 10269, 10270, 10272, 10276, 10279, 10280, 10281, 10282, 10283, 10284, 10287, 10288, 10292, 10294, 10295, 10297, 10298, 10300, 10302, 10303, 10305, 10307, 10308, 10309, 10311, 10312, 10313, 10314, 10316, 10319, 10320, 10323, 10325, 10326, 10328, 10332, 10333, 10334, 10335, 10336, 10336, 10337, 10338, 10339, 10340, 10342, 10343, 10345, 10346, 10347, 10348, 10352, 10353, 10354, 10355, 10357, 10359, 10360, 10362, 10363, 10364, 10366, 10367, 10368, 10370, 10371, 10373, 10374, 10375, 10376, 10377, 10378, 10379, 10381, 10382, 10383, 10384, 10385, 10386, 10387, 10388, 10389, 10390, 10392, 10393, 10395, 10396, 10397, 10398, 10399, 10400, 10401, 10401, 10402, 10403, 10405, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10416, 10417, 10420, 10422, 10424, 10425, 10426, 10428, 10431, 10434, 10435, 10436, 10437, 10438, 10439, 10445, 10446, 10447, 10448, 10449, 10450, 10453, 10454, 10456, 10457, 10458, 10459, 10460, 10461, 10462, 10463, 10466, 10467, 10468, 10470, 10473, 10474, 10475, 10476, 10477, 10479, 10480, 10481, 10483, 10485, 10486, 10487, 10488, 10489, 10491, 10493, 10494, 10495, 10498, 10501, 10504, 10505, 10507, 10508, 10510, 10511, 10512, 10514, 10516, 10518, 10519, 10520, 10521, 10522, 10525, 10526, 10527, 10529, 10530, 10531, 10532, 10533, 10534, 10537, 10538, 10539, 10540, 10541, 10542, 10543, 10544, 10545, 10547, 10548, 10548, 10550, 10551, 10552, 10553, 10555, 10556, 10557, 10558, 10559, 10560, 10561, 10562, 10563, 10564, 10565, 10568, 10571, 10572, 10573, 10574, 10575, 10576, 10578, 10579, 10581, 10582, 10584, 10585, 10586, 10587, 10589, 10590, 10591, 10592, 10593, 10594, 10595, 10596, 10597, 10598, 10599, 10600, 10601, 10603, 10605, 10606, 14119, 14258, 14286, 14335, 15004, 15006, 15009, 15010, 15011, 15012, 15013, 16001, 16002, 16004, 16005, 16006, 16007, 16008, 16009, 16010, 16010, 16013, 16014, 16015, 16016, 16017, 16018, 16019, 16020, 16021, 16022, 16023, 16024, 16026, 16027, 16028, 16029, 16030, 16033, 16035, 16036, 16037, 16038, 16039, 16040, 16041, 16043, 16044, 16045, 16046, 16048, 16049, 16050, 16051, 16052, 16053, 16054, 16055, 16056, 16057, 16058, 16059, 16060, 16061, 16062, 16063, 16065, 16066, 16067, 16068, 16069, 16070, 16071, 16072, 16073, 16074, 16075, 16076, 16078, 16079, 16081, 16082, 16083, 16084, 16085, 16086, 16088, 16089, 16090, 16092, 16093, 16094, 16095, 16096, 16097, 16098, 16099, 16101, 16103, 16104, 16106, 16107, 16108, 16109, 16110, 16111, 16112, 16113, 16114, 16115, 16116, 16118, 16119, 16120, 16121, 16122, 16123, 16124, 16125, 16126, 16127, 16128, 16129, 16130, 16131, 16132, 16133, 16134, 16135, 16136, 16137, 16138, 16139, 16140, 16141, 16142, 16143, 16145, 16146, 16148, 16149, 16151, 16152, 16153, 16154, 16155, 16156, 16157, 16158, 16159, 16160, 16162, 16163, 16164, 16166, 16168, 16169, 16170, 16171, 16171, 16172, 16173, 16174, 16175, 16176, 16177, 16178, 16179, 16180, 16182, 16183, 16184, 16185, 16186, 16188, 16189, 16190, 16191, 16192, 16193, 16194, 16195, 16196, 16197, 16198, 16199, 16200, 16201, 16202, 16203, 16204, 16205, 16207, 16208, 16209, 16210, 16211, 16212, 16213, 16214, 16215, 16216, 16217, 16218, 16219, 16220, 16221, 16222, 16223, 16224, 16225, 16227, 16228, 16229, 16231, 16232, 16233, 16234, 16235, 16236, 16237, 16238, 16239, 16239, 16240, 16241, 16242, 16243, 16244, 16245, 16246, 16248, 16249, 16250, 16251, 16252, 16253, 16254, 16255, 16256, 16258, 16259, 16260, 16261, 16262, 16263, 16264, 16265, 16266, 16267, 16268, 16269, 16270, 16271, 16272, 16273, 16274, 16275, 16276, 16277, 16278, 16279, 16280, 16281, 16282, 16283, 16284, 16285, 16286, 16287, 16288, 16289, 16290, 16292, 16293, 16294, 16295, 16296, 16297, 16298, 16299, 16300, 16301, 16302, 16303, 16304, 16305, 16306, 16307, 16308, 16309, 16310, 16311, 16312, 16313, 16315, 16316, 16317, 16318, 16319, 16320, 16321, 16322, 16323, 16324, 16325, 16326, 16327, 16329, 16330, 16331, 16332, 16333, 16334, 16335, 16336, 16337, 16338, 16339, 16340, 16341, 16342, 16343, 16344, 16345, 16346, 16347, 16348, 16349, 16350, 16352, 16353, 16354, 16355, 16356, 16357, 16358, 16359, 16360, 16361, 16362, 16363, 16364, 16366, 16367, 16368, 16369, 16370, 16371, 16372, 16374, 16375, 16376, 16377, 16378, 16379, 16380, 16381, 16382, 16383, 16384, 16385, 16386, 16387, 16388, 16389, 16390, 16392, 16393, 16394, 16395, 16396, 16397, 16398, 16399, 16400, 16401, 16402, 16403, 16404, 16405, 16406, 16407, 16408, 16409, 16410, 16411, 16412, 16413, 16414, 16415, 16416, 16417, 16418, 16419, 16420, 16421, 16422, 16423, 16424, 16425, 16426, 16427, 16428, 16429, 16429, 16430, 16431, 16432, 16433, 16434, 16435, 16436, 16437, 16438, 16439, 16440, 16441, 16442, 16443, 16444, 16445, 16446, 16447, 16448, 16449, 16450, 16451, 16452, 16453, 16454, 16455, 16456, 16457, 16458, 16459, 16460, 16461, 16462, 16463, 16464, 16465, 16466, 16467, 16468, 16469, 16470, 16471, 16474, 16475, 16475, 16476, 16477, 16478, 16479, 16480, 16481, 16482, 16483, 16484, 16485, 16486, 16487, 16488, 16489, 16490, 16491, 16493, 16494, 16495, 16496, 16497, 16498, 16499, 16500, 16501, 16502, 16503, 16504, 16505, 16506, 16507, 16508, 16509, 16510, 16511, 16512, 16513, 16514, 16515, 16515, 16516, 16517, 16518, 16519, 16520, 16521, 16522, 16523, 16524, 16525, 16526, 16527, 16528, 16529, 16530, 16531, 16532, 16533, 16534, 16535, 16536, 16537, 16538, 16539, 16540, 16541, 16542, 16543, 16544, 16545, 16546, 16547, 16548, 16549, 16550, 16551, 16552, 16553, 16554, 16555, 16556, 16557, 16558, 16559, 16560, 16561, 16562, 16563, 16564, 16565, 16566, 16567, 16569, 16570, 16571, 16572, 16573, 16574, 16575, 16576, 16577, 16578, 16579, 16580, 16581, 16582, 16583, 16584, 16585, 16586, 16587, 16588, 16589, 16590, 16591, 16592, 16593, 16594, 16595, 16596, 16597, 16598, 16599, 16601, 16602, 16604, 16605, 16606, 16607, 16608, 16609, 16610, 16611, 16612, 16613, 16614, 16615, 16616, 16617, 16618, 16619, 16620, 16621, 16622, 16623, 16624, 16625, 16626, 16627, 16628, 16629, 16630, 16631, 16632, 16633, 16634, 16635, 16636, 16637, 16638, 16639, 16640, 16641, 16642, 16643, 16644, 16645, 16646, 16647, 16648, 16649, 16651, 16652, 16653, 16654, 16655, 16656, 16657, 16658, 16659, 16660, 16661, 16662, 16663, 16664, 16665, 16666, 16667, 16668, 16669, 16670, 16671, 16672, 16673, 16674, 16675, 16676, 16678, 16679, 16680, 16681, 16682, 16683, 16684, 16685, 16686, 16687, 16688, 16689, 16690, 16691, 16692, 16693, 16694, 16695, 16696, 16697, 16698, 16699, 16700, 16701, 16702, 16703, 16704, 16705, 16706, 16707, 16708, 16709, 16710, 16711, 16712, 16713, 16714, 16715, 16716, 16717, 16718, 16719, 16720, 16721, 16723, 16724, 16725, 16726, 16727, 16728, 16729, 16730, 16731, 16732, 16733, 16734, 16735, 16736, 16737, 16738, 16739, 16740, 16741, 16742, 16743, 16744, 16745, 16746, 16747, 16748, 16749, 16750, 16751, 16752, 16753, 16754, 16755, 16756, 16757, 16758, 16759, 16760, 16761, 16762, 16764, 16765, 16766, 16767, 16768, 16769, 16770, 16771, 16772, 16773, 16774, 16775, 16776, 16777, 16778, 16779, 16780, 16781, 16782, 16783, 16784, 16785, 16786, 16787, 16788, 16789, 16790, 16791, 16792, 16793, 16794, 16795, 16796, 16797, 16798, 16799, 16800, 16801, 16802, 16802, 16803, 16804, 16805, 16806, 16807, 16808, 16809, 16810, 16811, 16812, 16813, 16815, 16816, 16817, 16818, 16819, 16820, 16821, 16822, 16823, 16824, 16825, 16826, 16827, 16828, 16829, 16830, 16831, 16832, 16833, 16834, 16835, 16836, 16837, 16838, 16839, 16840, 16841, 16842, 16843, 16844, 16845, 16846, 16848, 16849, 16850, 16851, 16851, 16852, 16853, 16854, 16855, 16856, 16857, 16858, 16859, 16860, 16861, 16862, 16863, 16864, 16865, 16866, 16867, 16868, 16869, 16870, 16871, 16872, 16873, 16874, 16875, 16877, 16878, 16879, 16880, 16881, 16882, 16883, 16884, 16885, 16886, 16887, 16888, 16889, 16891, 16892, 16893, 16894, 16895, 16896, 16897, 16898, 16899, 16900, 16901, 16902, 16903, 16904, 16905, 16906, 16907, 16908, 16909, 16910, 16911, 16912, 16913, 16914, 16915, 16916, 16917, 16918, 16919, 16920, 16921, 16922, 16923, 16924, 16925, 16926, 16927, 16928, 16929, 16930, 16931, 16932, 16933, 16934, 16935, 16936, 16937, 16938, 16939, 16940, 16941, 16942, 16943, 16944, 16945, 16946, 16947, 16948, 16949, 16950, 16951, 16952, 16953, 16954, 16955, 16956, 16957, 16958, 16959, 16960, 16961, 16962, 16963, 16964, 16965, 16966, 16967, 16968, 16969, 16970, 16971, 16972, 16973, 16974, 16975, 16976, 16977, 16979, 16980, 16981, 16982, 16983, 16984, 16985, 16986, 16987, 16988, 16989, 16990, 16991, 16992, 16993, 16994, 16995, 16996, 16997, 16998, 17000, 17001, 17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17016, 17017, 17018, 17019, 17020, 17021, 17022, 17023, 17024, 17025, 17026, 17027, 17028, 17029, 17030, 17031, 17032, 17034, 17035, 17036, 17037, 17038, 17039, 17040, 17041, 17042, 17043, 17045, 17046, 17047, 17048, 17049, 17050, 17051, 17052, 17053, 17054, 17055, 17055, 17056, 17057, 17058, 17059, 17060, 17061, 17062, 17063, 17064, 17065, 17066, 17067, 17068, 17069, 17070, 17071, 17072, 17073, 17074, 17075, 17076, 17077, 17078, 17079, 17080, 17081, 17082, 17083, 17084, 17085, 17086, 17088, 17089, 17090, 17091, 17092, 17093, 17094, 17095, 17096, 17097, 17098, 17099, 17100, 17101, 17102, 17103, 17104, 17105, 17107, 17108, 17109, 17110, 17111, 17112, 17113, 17114, 17115, 17116, 17117, 17118, 17119, 17120, 17121, 17122, 17123, 17124, 17125, 17126, 17127, 17128, 17129, 17130, 17131, 17132, 17133, 17134, 17135, 17136, 17137, 17138, 17139, 17140, 17141, 17142, 17143, 17144, 17146, 17147, 17148, 17149, 17150, 17151, 17152, 17153, 17154, 17155, 17156, 17157, 17158, 17159, 17160, 17161, 17162, 17163, 17164, 17165, 17166, 17166, 17167, 17168, 17169, 17170, 17171, 17172, 17173, 17174, 17175, 17176, 17177, 17178, 17179, 17182, 17184, 17185, 17186, 17187, 17188, 17189, 17190, 17191, 17192, 17193, 17194, 17195, 17196, 17197, 17198, 17199, 17200, 17201, 17203, 17204, 17205, 17206, 17207, 17208, 17210, 17211, 17212, 17213, 17214, 17215, 17216, 17217, 17218, 17219, 17220, 17221, 17222, 17223, 17224, 17225, 17226, 17227, 17228, 17229, 17230, 17231, 17232, 17233, 17234, 17235, 17236, 17237, 17238, 17239, 17240, 17241, 17242, 17244, 17245, 17246, 17247, 17248, 17249, 17250, 17251, 17252, 17253, 17254, 17255, 17256, 17257, 17258, 17259, 17260, 17261, 17262, 17263, 17264, 17265, 17266, 17267, 17268, 17269, 17270, 17271, 17272, 17273, 17274, 17275, 17276, 17277, 17278, 17279, 17281, 17282, 17283, 17284, 17285, 17286, 17287, 17288, 17289, 17290, 17291, 17292, 17293, 17294, 17295, 17296, 17297, 17298, 17299, 17300, 17301, 17302, 17303, 17304, 17305, 17306, 17307, 17308, 17309, 17310, 17311, 17312, 17313, 17314, 17315, 17316, 17317, 17318, 17319, 17320, 17321, 17322, 17323, 17324, 17325, 17326, 17327, 17329, 17330, 17331, 17332, 17333, 17334, 17335, 17336, 17337, 17338, 17339, 17340, 17341, 17342, 17343, 17346, 17347, 17348, 17349…
Recall started: Feb. 7, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Device Design
What the company told customers: GE sent an Urgent Medical Device Correction letter, dated 2/7/2014 to medical facilities beginning 2/7/2014. The letter was addressed to Manager of Nuclear Medicine, Hospital Administrators/Risk Managers, and Managers of Radiology/Cardiology. The letter described the issue and provided safety instructions. For Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam nuclear Medicine Systems, the letter stated that a software upgrade would correct the issue. For the Helix Nuclear Medicine Systems, GE stated that a software upgrade can not be applied to the older systems and that additional information will be provided at a later date. UPDATE ON THE HELIX DEVICES: An Urgent Medical Device Correction letter, dated 4/7/2014 was sent to customers who still have a GE Helix Nuclear Medicine System. The letter requested to immediately stop using the device, and reiterated the March 2008 letter in which GE stated that they would no longer be able to offer full service support. The main reason for this was due to unavailability of parts required for maintenance and repair of the device because outside suppliers cease to produce the older parts. GE offered assistance in removal and disposal of the Helix system.
Recall number: Z-1198-2014

GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to…

Product: GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Quantity: 3062 units (1182 US, 1880 OUS)
Codes and lots: all serial numbers are listed in Product 1
Recall started: Feb. 7, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Device Design
What the company told customers: GE sent an Urgent Medical Device Correction letter, dated 2/7/2014 to medical facilities beginning 2/7/2014. The letter was addressed to Manager of Nuclear Medicine, Hospital Administrators/Risk Managers, and Managers of Radiology/Cardiology. The letter described the issue and provided safety instructions. For Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam nuclear Medicine Systems, the letter stated that a software upgrade would correct the issue. For the Helix Nuclear Medicine Systems, GE stated that a software upgrade can not be applied to the older systems and that additional information will be provided at a later date. UPDATE ON THE HELIX DEVICES: An Urgent Medical Device Correction letter, dated 4/7/2014 was sent to customers who still have a GE Helix Nuclear Medicine System. The letter requested to immediately stop using the device, and reiterated the March 2008 letter in which GE stated that they would no longer be able to offer full service support. The main reason for this was due to unavailability of parts required for maintenance and repair of the device because outside suppliers cease to produce the older parts. GE offered assistance in removal and disposal of the Helix system.
Recall number: Z-1199-2014

Elscint APEX Helix…

Product: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Quantity: 3062 units (1182 US, 1880 OUS)
Codes and lots: all serial numbers are listed in Product 1.
Recall started: Feb. 7, 2014
Device type: System, Tomography, Computed, Emission
Root cause (FDA): Device Design
What the company told customers: GE sent an Urgent Medical Device Correction letter, dated 2/7/2014 to medical facilities beginning 2/7/2014. The letter was addressed to Manager of Nuclear Medicine, Hospital Administrators/Risk Managers, and Managers of Radiology/Cardiology. The letter described the issue and provided safety instructions. For Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam nuclear Medicine Systems, the letter stated that a software upgrade would correct the issue. For the Helix Nuclear Medicine Systems, GE stated that a software upgrade can not be applied to the older systems and that additional information will be provided at a later date. UPDATE ON THE HELIX DEVICES: An Urgent Medical Device Correction letter, dated 4/7/2014 was sent to customers who still have a GE Helix Nuclear Medicine System. The letter requested to immediately stop using the device, and reiterated the March 2008 letter in which GE stated that they would no longer be able to offer full service support. The main reason for this was due to unavailability of parts required for maintenance and repair of the device because outside suppliers cease to produce the older parts. GE offered assistance in removal and disposal of the Helix system.
Recall number: Z-1200-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1198-2014, Z-1199-2014, Z-1200-2014. The agency record governs; check it and the company before acting.

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