Philips Medical Systems Nederland B.V.
Eindhoven Noord-Brabant, NL
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. appears in FDA device records in Eindhoven Noord-Brabant, NL. FDA records list 115 510(k) clearances between and , no PMA records and 7 registered establishments. As of , FDA records show 292 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Philips Medical Systems Nederland B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Philips Medical Systems Nederlands B.V.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 115FDA records hold 115 510(k) clearances for Philips Medical Systems Nederland B.V. between 2005 and 2026. The busiest year on record is 2018, with 12. The most recent is 2026, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 11 |
| 2014 | 6 |
| 2015 | 4 |
| 2016 | 10 |
| 2017 | 11 |
| 2018 | 12 |
| 2019 | 3 |
| 2020 | 6 |
| 2021 | 9 |
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 10 |
| 2025 | 8 |
| 2026 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254205 | Zenition 30 | OWB | Substantially Equivalent | |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | MOS | Substantially Equivalent | |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | MOS | Substantially Equivalent | |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | MUJ | Substantially Equivalent | |
| K253614 | EchoNavigator R5.0 | QIH | Substantially Equivalent | |
| K260169 | AV Cardiac CT | JAK | Substantially Equivalent | |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | LNH | Substantially Equivalent | |
| K253735 | AV Vascular | QIH | Substantially Equivalent | |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | MOS | Substantially Equivalent | |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | DQK | Substantially Equivalent | |
| K251215 | Philips IntelliSpace Cardiovascular | LLZ | Substantially Equivalent | |
| K250181 | AV Viewer | LLZ | Substantially Equivalent | |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | LNH | Substantially Equivalent | |
| K250648 | Philips iCT CT system | JAK | Substantially Equivalent | |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | LNH | Substantially Equivalent | |
| K242001 | Philips VSC-MEDlib | BZQ | Substantially Equivalent | |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | PSY | Substantially Equivalent | |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | PSY | Substantially Equivalent | |
| K241871 | Philips IntelliSite Pathology Solution | PSY | Substantially Equivalent | |
| K242512 | ROCC Console | LLZ | Substantially Equivalent | |
| K243033 | dS Wrist coil 8ch 1.5T | MOS | Substantially Equivalent | |
| K242879 | dS Knee Coil 8ch 1.5T | MOS | Substantially Equivalent | |
| K242096 | dS FootAnkle Coil 8ch 1.5T | MOS | Substantially Equivalent | |
| K233204 | Philips IntelliSite Pathology Solution 5.1 | PSY | Substantially Equivalent | |
| K240224 | Zenition 90 | OWB | Substantially Equivalent | |
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | DQK | Substantially Equivalent | |
| K232420 | Zenition 30 | OWB | Substantially Equivalent | |
| K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | LNH | Substantially Equivalent | |
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | DQK | Substantially Equivalent | |
| K230972 | Ingenia Elition and MR 7700 MR Systems | LNH | Substantially Equivalent | |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | LNH | Substantially Equivalent | |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | LNH | Substantially Equivalent | |
| K221270 | EchoNavigator R4.0 | LLZ | Substantially Equivalent | |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | LNH | Substantially Equivalent | |
| K212875 | Spectral CT on Rails | JAK | Substantially Equivalent | |
| K213516 | Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei | LNH | Substantially Equivalent | |
| K210760 | Precise Image | JAK | Substantially Equivalent | |
| K212673 | MR 5300 | LNH | Substantially Equivalent | |
| K212813 | Zenition 70 | OWB | Substantially Equivalent | |
| K203845 | Philips IntelliSite Pathology Solution | PSY | Substantially Equivalent | |
| K201573 | Brain Perfusion (BP) application | LLZ | Substantially Equivalent | |
| K211764 | Vereos PET/CT | KPS | Substantially Equivalent | |
| K210880 | Vereos PET/CT | KPS | Substantially Equivalent | |
| K203020 | Spectral CT | JAK | Substantially Equivalent | |
| K201743 | ClarifEye R1.0, ClarifEye Needle | OWB | Substantially Equivalent | |
| K201583 | SmartCT R1.0 | OWB | Substantially Equivalent | |
| K203216 | The Multimodality Advanced Vessel Analysis | JAK | Substantially Equivalent | |
| K192914 | Stimuplex Onvision System | BSP | Substantially Equivalent | |
| K200917 | Azurion R2.1 | OWB | Substantially Equivalent | |
| K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003768277 | 3002807880 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | VEENPLUIS 6, BEST Noord-Brabant 5684 PC NL | 2026 | and 26 more, listed in full below |
| 3042175841 | 3042175841 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | VEENPLUIS 6, Best Noord-Brabant 5684 PC NL | 2026 | |
| 3042175844 | 3042175844 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | VEENPLUIS 6, BEST Noord-Brabant 5684 PC NL | 2026 | and 2 more, listed in full below |
| 3042177665 | 3042177665 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | VEENPLUIS 6, BEST Noord-Brabant 5684 PC NL | 2026 | |
| 3000976525 | 3000976525 | Philips Medical Systems Nederland B.V. | High Tech Campus 36, Eindhoven Noord-Brabant 5656 AE NL | 2026 | |
| 3012563754 | 3012563754 | Philips Medical Systems Nederland B.V. | Veenpluis 6, Best Noord-Brabant 5684 PC NL | 2026 | |
| 3015777306 | 3015777306 | Philips Medical Systems Nederland B.V. | Veenpluis 6, Best Noord-Brabant 5684 PC NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- OEOAutomated Digital Image Manual Interpretation Microscope
- QIHAutomated Radiological Image Processing Software
- PXPBreast Biopsy / Localization Tray
- MOSCoil, Magnetic Resonance, Specialty
- IZWCollimator, Automatic, Radiographic
- IZXCollimator, Manual, Radiographic
- DQKComputer, Diagnostic, Programmable
- KZFDevice, Medical Examination, Ac Powered
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- IXJGrid, Radiographic
- GDFGuide, Needle, Surgical
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- IWYHolder, Head, Radiographic
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- DXTInjector And Syringe, Angiographic
- LHOInstrument, Quality-Assurance, Radiologic
- OWBInterventional Fluoroscopic X-Ray System
- BZQMonitor, Breathing Frequency
- IWEMonitor, Patient Position, Light-Beam
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- LHISet, I.V. Fluid Transfer
- KPYShield, Protective, Personnel
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- MSXSystem, Network And Communication, Physiological Monitors
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- MUJSystem, Planning, Radiation Therapy Treatment
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- FQOTable, Operating-Room, Ac-Powered
- IZZTable, Radiographic, Non-Tilting, Powered
- IXQTable, Radiographic, Stationary Top
- KXJTable, Radiologic
- IXFTest-Pattern, Radiographic
- IYBTube Mount, X-Ray, Diagnostic
- PSYWhole Slide Imaging System
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 292| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2932-2026 | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system | Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications. | Class II | Open, Classified | |
| Z-2931-2026 | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications | Class II | Open, Classified | |
| Z-2928-2026 | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system. | Firmware issue potentially leading to loss of geometry movements. | Class II | Open, Classified | |
| Z-2893-2026 | Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | Class II | Open, Classified | |
| Z-2892-2026 | Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | Class II | Open, Classified | |
| Z-2891-2026 | Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. Interventional Fluoroscopic X-Ray System. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. | Class II | Open, Classified | |
| Z-2412-2026 | Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table. | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection | Class II | Open, Classified | |
| Z-2411-2026 | Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector. | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection | Class II | Open, Classified | |
| Z-2259-2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039); | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality. | Class II | Open, Classified | |
| Z-2258-2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224). | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality. | Class II | Open, Classified | |
| Z-2225-2026 | Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282. | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. | Class II | Open, Classified | |
| Z-2229-2026 | Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016); | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. | Class II | Open, Classified | |
| Z-2228-2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400); | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. | Class II | Open, Classified | |
| Z-2227-2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224). | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. | Class II | Open, Classified | |
| Z-2170-2026 | Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282). | Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. | Class II | Open, Classified | |
| Z-1805-2026 | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data. | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions. | Class II | Open, Classified | |
| Z-1692-2026 | Vue Motion V12. Product Number: 1017979. | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. | Class II | Open, Classified | |
| Z-1680-2026 | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1679-2026 | Azurion 5 M12; System Code: (1)722227, (2)722231; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1678-2026 | Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1677-2026 | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1676-2026 | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1675-2026 | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1674-2026 | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified | |
| Z-1673-2026 | Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain