Back to search
FDAFDA · Food and drugs·Recall number 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.

Published July 31, 2013 · Recall initiated: June 13, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare, LLC
Distributor
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.
Lot
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
Risk classification
Class I
Area (FDA)
device
Country
United States

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card