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
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling approximately 571 Infinia Hawkeye 4 Nuclear Medicine Systems worldwide after becoming aware of an incident at a VA Medical Center in the United States in which a patient died from injuries sustained while being scanned on one of these devices. The affected systems have been distributed nationwide in the US as well as in Guam, Puerto Rico, and numerous countries including Canada, Australia, Japan, France, Germany, India, and many others.
The recall notice does not specify a remedy or recommended course of action for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Reason for recall: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. Distribution: Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, 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, Quantity: 571 Lot/code info: System ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, 082426130012, 082426130013, 082426130014, 082426130015, 082426130016, 082426130019, 082426140005, 082426140007, 082426140008, 082426140009, 082426140011, 082426140012, 082426150003, 082426150006, 082426160012, 082426160014, 082426160016, 082426160017, 082426160019, 082426160020, 082426160022, 082426160023, 082426180003, 082426190008, 082426190010, 082426200002, 082426210002, 082426210003, 082426210010, 082426220006, 082426230008, 082426230010, 082426250002, 082426280001, 082426290004, 08242631000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.