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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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Product Description
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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
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
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508P... 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
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 Product Usage: The intended use of the Quasar system... 2 03/13/2014 GE Healthcare, LLC
GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle ... 2 03/13/2014 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 Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for... 1 07/24/2013 GE Healthcare, LLC
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