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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 19 Results
510(K) Number: K022960
 
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Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H... 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
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, ... 2 12/16/2014 GE Healthcare, LLC
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The int... 2 03/13/2014 GE Healthcare, LLC
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia I... 2 12/16/2014 GE Healthcare, LLC
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for... 1 07/24/2013 GE Healthcare, LLC
GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use: To perform g... 2 04/10/2009 GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY ... 2 04/10/2009 GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye® 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. Produc... 2 04/21/2009 GE Medical Systems, LLC
GE Healthcare Infinia Hawkeye®, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. Pr... 2 04/21/2009 GE Medical Systems, LLC
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