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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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GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC... 2 01/10/2025 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS;... 2 01/10/2025 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H300... 2 01/10/2025 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Co... 2 01/10/2025 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia I... 2 12/16/2014 GE Healthcare, LLC
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508P... 2 12/16/2014 GE Healthcare, LLC
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, ... 2 12/16/2014 GE Healthcare, LLC
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3... 2 12/16/2014 GE Healthcare, LLC
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H... 2 12/16/2014 GE Healthcare, LLC
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
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