Interventional fluoroscopic x-ray system

FDA product code OWB · Class 2 · 88 devices · 29,124 reports · 32 deaths reported · 80 devices named in recalls

• Allura Xper FD Allura Xper FD20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  25 recalls2 deaths3,984 reports
• Allura Xper FD Allura Xper FD20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls2 deaths3,614 reports
• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  32 recalls2 deaths2,308 reports
• O-ARM® BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  2 recalls1 death3,667 reports
• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  28 recalls1 death2,176 reports
• Allura Xper FD Allura Xper FD10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls2 deaths2,015 reports
• Allura Xper FD Allura Xper FD10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths1,837 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths1,087 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls2 deaths835 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls1 death634 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls594 reports
• Allura Xper FD Allura Xper FD20/15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths776 reports
• Allura Xper FD Allura Xper FD20 Biplane

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  16 recalls3 deaths792 reports
• Allura Xper FD Allura Xper FD10/10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  19 recalls603 reports
• Azurion Azurion 5 M20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  24 recalls201 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  23 recalls232 reports
• Allura Xper FD Allura Xper FD20 OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  18 recalls411 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls222 reports
• Azurion Azurion 5 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls1 death197 reports
• Azurion Azurion 3 M15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls2 deaths205 reports
• Azurion Azurion 3 M15

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  21 recalls104 reports
• Allura Xper FD Allura Xper FD20/20

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  18 recalls250 reports
• Allura Xper FD Allura Xper FD20/10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  19 recalls172 reports
• Azurion Azurion 3 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls121 reports
• Azurion Azurion 3 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  20 recalls73 reports
• Allura Xper FD Allura Xper FD20 OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  15 recalls246 reports
• Allura Xper FD Allura Xper FD10/10

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  10 recalls449 reports
• ARTIS pheno 10849000

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  14 recalls64 reports
• Azurion Azurion 7 M20

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  11 recalls1 death108 reports
• Allura Xper FD Allura Xper FD20/15 OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  12 recalls16 reports
• O-arm BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  2 recalls466 reports
• Azurion Azurion 7 B12

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  11 recalls5 reports
• Azurion Azurion 7 B20

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  10 recalls1 death50 reports
• Azurion Azurion 7 M12

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  10 recalls27 reports
• Azurion Azurion 5 M12

  Philips Medical Systems Nederland B.V. · Interventional fluoroscopic x-ray system
  8 recalls8 reports
• Allura Xper FD Allura Xper FD20/20 OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  7 recalls13 reports
• Allura Xper FD Allura Xper FD20 Biplane OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  7 recalls2 reports
• O-ARM® BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  1 recall287 reports
• HeartNavigator HeartNavigator - 2

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  6 recalls3 reports
• Artis zeego 10848283

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  5 recalls1 death7 reports
• Allura Xper FD Allura Xper FD10 OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  5 recalls6 reports
• Allura Xper FD Allura Xper FD10 OR Table

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  5 recalls1 report
• OEC 9800 PLUS

  Oec Medical Systems, Inc. · Interventional fluoroscopic x-ray system
  5 recalls0 reports
• Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 1

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  5 recalls0 reports
• Artis zeego 10280959

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  4 recalls1 death24 reports
• Artis Q.zen biplane 10848355

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  4 recalls5 reports
• OEC 3D

  Oec Medical Systems, Inc. · Interventional fluoroscopic x-ray system
  4 recalls0 reports
• Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 2

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  4 recalls0 reports
• Veradius Veradius Unity

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  2 recalls55 reports
• EmboGuide EmboGuide - 1

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  3 recalls2 reports
• StentBoost StentBoost - 4

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  3 recalls1 report
• OEC 9900 ELITE

  Oec Medical Systems, Inc. · Interventional fluoroscopic x-ray system
  3 recalls0 reports
• 3D Roadmap 3D Roadmap - 1

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  3 recalls0 reports
• Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 3

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  2 recalls10 reports
• LUMINOS Lotus Max 11574100

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  2 recalls7 reports
• StentBoost Live StentBoost Live - 2

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  2 recalls2 reports
• EP navigator EP navigator - 5

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  2 recalls0 reports
• Intelli-C Right Side Suspended Table 03400000

  Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System
  2 recalls0 reports
• O-arm O2 BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  1 recall33 reports
• O-ARM® BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  1 recall20 reports
• Artis one 10848600

  Siemens Shenzhen Magnetic Resonance Ltd. · Interventional fluoroscopic x-ray system
  1 recall1 death19 reports
• Luminos dRF Max 10762471

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  1 recall17 reports
• BV Pulsera

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  1 recall10 reports
• Cios Alpha 11105200

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  1 recall1 death6 reports
• BV Endura

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  1 recall1 report
• Intelli-C Accessory 03282000

  Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System
  1 recall1 report
• Allia IGS 7 OR 001

  Ge Medical Systems · Interventional fluoroscopic x-ray system
  1 recall0 reports
• INNOVA IGS 6 001

  Ge Medical Systems · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• SyncVision System 400-0100.10

  Philips Image Guided Therapy Corporation · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• MC2 Portable X-ray System MC2.1

  OXOS Medical, Inc. · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• TrackX INSIGHT™ BASE-5L

  TrackX Technology, LLC · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• TrackX INSIGHT™ BASE-6.5L

  TrackX Technology, LLC · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• TrackX INSIGHT™ BASE FLEX-8

  TrackX Technology, LLC · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• MC2 Portable X-ray System

  OXOS Medical, Inc. · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• 2D Perfusion 2D Perfusion - 1

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• Allura Xper FD Allura Xper R9 7 M12

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• Cios Select 11020806

  Siemens Shanghai Medical Equipment Ltd. · Interventional fluoroscopic x-ray system
  1 recall0 reports
• Cios Flow 11108110

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  1 recall0 reports
• LUMINOS Q.namix T 11574003

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  1 recall0 reports
• Intelli-C Accessory 03283000

  Nrt - Nordisk Røntgen Teknik A/S · Interventional Fluoroscopic X-Ray System
  1 recall0 reports
• O-arm BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  17 reports
• O-ARM® BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  16 reports
• Multitom Rax 10860700

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  3 reports
• INTERVENTIONAL ANGIOGRAPHY SYSTEM INFX-8000V

  Canon Inc. · Interventional fluoroscopic x-ray system
  1 death3 reports
• O-ARM® BI70002000

  Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
  1 report
• XperGuide XperGuide - 1

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  1 report
• StentBoost Live StentBoost Live - 1

  Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
  1 report
• MULTIPURPOSE REMOTE CONTROL R/F SYSTEM DREX-UI80

  Canon Inc. · Interventional fluoroscopic x-ray system
  1 report