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
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled approximately 50 Infinia Hawkeye 4 Nuclear Medicine Systems that were distributed worldwide, including throughout the United States, Guam, Puerto Rico, and numerous countries across multiple continents. The recall was initiated after GE became aware of a patient death that occurred at a VA Medical Center facility in the US. The patient sustained injuries while being scanned on one of these systems.
The recalled systems are identified by specific system IDs and lot codes listed in the recall record. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 50 Lot/code info: System ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.