GE Healthcare Infinia Hawkeye 4 Option 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 g
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled 2,474 Infinia Hawkeye 4 Option and Hawkeye Option dual-head variable angle gamma camera systems distributed worldwide after becoming aware of an incident at a VA Medical Center facility in the United States where a patient died from injuries sustained while being scanned on one of these nuclear medicine systems.
The recall affects systems distributed across the United States, including Guam and Puerto Rico, as well as multiple countries worldwide. The specific system identification numbers involved in the recall are listed in the recall record. The source does not specify a remedy or recommended action for affected consumers.
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: 2474 Lot/code info: System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 0850260115, 0850260117, 0850260119, 0850260120, 0850260121, 0850260123, 0850260124, 0850260127, 0850260129, 0850260130, 0850260133, 0853260020, 0853260023, 0853260024, 0853260025, 0853260029, 0853260030, 0853260032, 0853260035, 0853260036, 0853260039, 0853260040, 0853260042, 0853260045, 0853260046, 0853260056, 0853260062, 0853260066, 0853260069, 0853260072, 0853260074, 0853260087, 0853260100, 0853260103, 0853260105, 0853260113, 853260118, 0853260119, 0856260023, 0856260024, 0856260025, 0856260026, 085626
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.