84 results
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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 3, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 11, 2024
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 27, 2023
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 Allura Xper FD10 OR Table 722035 Allura Xper FD20 OR Table 722043 Integris Allura 15 & 12 (monoplane) 72246 Poly G - OMCP - VISUB - CCD (H5000)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 27, 2023
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019
Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·March 6, 2019