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
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled 3,062 units of Infinia and Infinia Hawkeye Nuclear Medicine Systems with dual-head variable angle gamma cameras distributed worldwide, including throughout the United States, Puerto Rico, Guam, and numerous other countries. The recall addresses a potential safety issue involving unintended radial detector motion that may occur during patient setup or at the end of a patient scan. This problem was observed in a single system where the detector moved to its home position and then slowly drifted inward toward the patient, triggering both visual and audio alerts on both the console and gantry.
The affected devices can be identified by specific serial numbers listed in the recall documentation. The source document does not specify what remedy consumers should take or what steps affected facility operators should follow.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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: 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, Kor Quantity: 3062 units (1182 US, 1880 OUS) Lot/code info: 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, 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.