428 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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SIGNA Premier systems
FDA Enforcement
Class II
·Ongoing·GE Healthcare LLC·April 8, 2026
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·April 13, 2022
Revolution CT, Revolution CT ES
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·April 13, 2022
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 6, 2022
Centricity Radiology RA600
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity PACS RA1000
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity Universal Viewer Zero Footprint Client
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Centricity Enterprise Web
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 2, 2022
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·April 27, 2022
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·December 1, 2021
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 2, 2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·July 6, 2022
Centricity Cardiology CA1000
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·June 15, 2022
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·January 16, 2019
Revolution Apex, Revolution CT with Apex Edition
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·April 13, 2022
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·February 2, 2022