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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1787-2013

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 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.

Publicado el 31 de julio de 2013 · Inicio del retiro: 13 de junio de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare, LLC
Distribuidor
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, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
Lote
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, 0856260028, 856260029, 0856260030, 0856260031, 0856260032, 859260010, 0910262170, 0910262196, 0910262205, 0910262210, 0910262214, 0910262217, 0910262220, 0910262225, 0910262227, 0910262229, 0910262234, 0910262236, 0910262239, 0910262241, 0910262244, 0910262249, 0910262255, 0910262257, 0910262263, 0910262266, 0910262269, 0910262276, 0910262279, 0910262280, 0910262285, 0910262288, 0910262291, 0910262293, 0910262295, 0910262301, 0910262307, 0910262312, 0910262332, 0910262335, 0910262338, 910262349, 0910263135, 0910263143, 0910263157, 0910263159, 0910263161, 0910263166, 0910263190, 0910263198, 0910263204, 0910263207, 0910263210, 0910264058, 0910264060, 0910264062, 0910264067, 0910264069, 0910264072, 0910264075, 0910264077, 0910264079, 0910264081, 0910264083, 0910264085, 0910264089, 0910264091, 0910264095, 0910264098, 0910264100, 0910264102, 0910264105, 0910264107, 0910264112, 0910264115, 0910264121, 0910264123, 0910264126, 0910264129, 0910264136, 0910264137, 0910264145, 0910264152, 0910265050, 0910265053, 0910265055, 0910265059, 0910265063, 0910265066, 0910265068, 0910265072, 0910266042, 0910266045, 0910266050, 0910266053, 0910266063, 0910266067, 0910267010, 0910267015, 0910267020, 0920269079, 0920269081, 0920269082, 0920269087, 0920269092, 0920269093, 082426010014, 082426020005, 082426030020, 082426030021, 082426030022, 082426040030, 082426040033, 082426040034, 082426040035, 082426040036, 082426040037, 082426040038, 082426040039, 082426040041, 082426040042, 082426040045, 082426040048, 082426040049, 082426040050, 082426050004, 082426050005, 082426050007, 082426070018, 082426070019, 082426070020, 082426070022, 082426070023, 082426070024, 082426070025, 082426070033, 082426080010, 082426080012, 082426080014, 082426080018, 082426080019, 082426090016, 082426090017, 082426090018, 082426090020, 082426090021, 082426090022, 082426090023, 082426090024, 082426090026, 082426090027, 082426090028, 082426090033, 082426100028, 082426100032, 082426100033, 082426100035, 082426100036, 082426100037, 082426100038, 082426100041, 082426100043, 082426100044, 082426100046, 082426100047, 082426100048, 082426110004, 082426110006, 082426110007, 082426110008, 082426110009, 082426110010, 082426120006, 082426120007, 082426120011, 082426120013, 082426120015, 082426120016, 082426120017, 082426120018, 082426120019, 082426120020, 082426120021, 082426120022, 082426130020, 082426130021, 082426130023, 082426130024, 082426130025, 082426130026, 082426130027, 082426130031, 082426130032, 082426130033, 0824
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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