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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 23 Results
510(K) Number: K022960
 
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Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is in... 2 12/16/2014 GE Healthcare, LLC
GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 ... 2 04/10/2009 GE Medical Systems, LLC
GE Healthcare, Infinia Hawkeye® 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. Th... 2 04/10/2009 GE Medical Systems, LLC
GE Healthcare, Hawkeye® for Infinia, Model Numbers: H3000WR , H3000WW, H3000WZ , H3000YM and H3000YS... 2 04/10/2009 GE Medical Systems, LLC
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508P... 2 12/16/2014 GE Healthcare, LLC
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system... 2 03/13/2014 GE Healthcare, LLC
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Vari... 2 04/10/2013 GE Healthcare, LLC
GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM001473, ASM001... 2 04/21/2009 GE Medical Systems, LLC
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle ... 2 03/13/2014 GE Healthcare, LLC
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Co... 2 01/10/2025 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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