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.

Recall details

Manufacturer

GE Healthcare, LLC

Distributor

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.

Lot

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, 1

Risk classification

Class II

Area (FDA)

device

Country

United States