137 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·January 20, 2021
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: 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 imaging features designed to enhance image quality.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·January 20, 2021
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·January 20, 2021
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
SIGNA Premier magnetic resonance scanner, model 5748519.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 27, 2022
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·March 23, 2022
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·August 4, 2021
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 16, 2022
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 27, 2022