System, image processing, radiological

FDA product code LLZ · Class 2 · 162 devices · 1,194 reports · 6 deaths reported · 95 devices named in recalls

• Interventional Workspot Interventional Workspot - 1

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  13 recalls24 reports
• Synapse Radiology PACS Synapse Radiology PACS Software License

  Fujifilm Healthcare Americas Corporation · System, image processing, radiological
  9 recalls38 reports
• CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 6.0

  Ge Healthcare · System, image processing, radiological
  8 recalls0 reports
• CENTRICITY UNIVERSAL VIEWER 6.0

  Ge Healthcare · System, image processing, radiological
  8 recalls0 reports
• CENTRICITY UNIVERSAL VIEWER 7.0

  Ge Healthcare · System, image processing, radiological
  6 recalls0 reports
• IntelliSpace Cardiovascular 8

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  2 recalls132 reports
• CA1000 2.0 SP 14

  Ge Healthcare · System, image processing, radiological
  4 recalls0 reports
• VMA 2

  Ortho Kinematics, Inc. · System, Image Processing, Radiological
  4 recalls0 reports
• IntelliSpace Cardiovascular 7

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  2 recalls99 reports
• EPIQ Elite Diagnostic Ultrasound System 795234

  Philips Ultrasound LLC · System, Image Processing, Radiological
  3 recalls39 reports
• IntelliSpace Cardiovascular 6

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  1 recall118 reports
• VesselNavigator VesselNavigator - 1

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  3 recalls1 report
• Centricity CPACS 6.0

  Ge Healthcare · System, image processing, radiological
  3 recalls0 reports
• Centricity CPACS 7.0

  Ge Healthcare · System, image processing, radiological
  3 recalls0 reports
• Site-Rite 9770500

  Bard Access Systems, Inc. · System, image processing, radiological
  140 reports
• EPIQ CVx Diagnostic Ultrasound System 795231

  Philips Ultrasound LLC · System, Image Processing, Radiological
  119 reports
• Merge Cardio V11.1

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  2 recalls14 reports
• Merge Cardio 10.3

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  2 recalls13 reports
• Merge Cardio 11.0

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  2 recalls8 reports
• Vue PACS (Diagnostic) Vue PACS (Diagnostic) - 12

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  2 recalls3 reports
• Enterprise Imaging XERO Viewer 8

  Agfa HealthCare NV · System, Image Processing, Radiological
  2 recalls2 reports
• Merge PACS 9.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  2 recalls1 report
• True 3D Viewer EP-00003

  Echopixel, Inc. · System, Image Processing, Radiological
  2 recalls1 report
• Change Healthcare Radiology Solutions 14.0

  Change Healthcare Canada Company · System, Image Processing, Radiological
  2 recalls1 report
• Universal Viewer 8

  Ge Healthcare · System, image processing, radiological
  2 recalls0 reports
• AW Server 3.2

  Ge Medical Systems · System, image processing, radiological
  2 recalls0 reports
• Centricity CPACS 4.0

  Ge Healthcare · System, image processing, radiological
  2 recalls0 reports
• mintLesion™ 3.9.0

  Mint Medical GmbH · System, Image Processing, Radiological
  2 recalls0 reports
• 3mensio Workstation 10.7

  Pie Medical Imaging B.V. · System, Image Processing, Radiological
  2 recalls0 reports
• BD Prevue II Peripheral Vascular Access System 9770703

  Bard Access Systems, Inc. · System, image processing, radiological
  93 reports
• Merge Cardio 12.1

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall1 death8 reports
• EPIQ CVxi Ultrasound System 795232

  Philips Ultrasound LLC · System, Image Processing, Radiological
  1 recall7 reports
• Merge Cardio 12.0.1

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall4 reports
• Vue PACS Vue PACS - 12

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  1 recall4 reports
• Merge PACS 8.1

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall3 reports
• Merge Cardio 12.3

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall3 reports
• Affiniti 70 Ultrasound System 795210

  Philips Ultrasound LLC · System, Image Processing, Radiological
  1 recall3 reports
• IntelliSpace Cardiovascular 5

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  52 reports
• GPS 531-07-05

  Exactech, Inc. · System, image processing, radiological
  1 recall2 reports
• Merge Cardio 12.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall1 report
• Merge PACS 8.0

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall1 report
• Merge PACS 9.5

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall1 report
• Synapse CardioVascular Synapse Cardiology PACS Software License

  Fujifilm Healthcare Americas Corporation · System, image processing, radiological
  1 recall1 report
• OBView 4.8

  Digisonics Inc · System, Image Processing, Radiological
  1 recall1 report
• vRad PACS 2

  Virtual Radiologic Corporation · System, Image Processing, Radiological
  1 recall1 death1 report
• Vue Motion Vue Motion - 12

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  1 recall1 report
• EPIQ 7 Ultrasound System 795200

  Philips Ultrasound LLC · System, Image Processing, Radiological
  1 recall1 report
• Change Healthcare Stratus Imaging PACS 1.4.0

  Change Healthcare Canada Company · System, Image Processing, Radiological
  1 recall1 report
• TheraSphere 360™ M00139509001

  Boston Scientific Corporation · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6. ver14

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6. ver15

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• ImageDrive Clinical 1.1

  Synaptive Medical Inc · System, Image Processing, Radiological
  1 recall0 reports
• ClearCanvas Personal Edition Workstation 13.1

  Synaptive Medical Inc · System, Image Processing, Radiological
  1 recall0 reports
• VSP System Scapula Marking Guide

  3d Systems, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• ViewPoint 6 ver 6.7

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6 ver6.8

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• Centricity CPACS RA1000 4.0

  Ge Healthcare · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6. ver6.9

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6. ver10

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6. ver11

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• ViewPoint 6. ver12

  GE Healthcare GmbH · System, image processing, radiological
  1 recall0 reports
• Merge PACS 7.3

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Merge OrthoPACS 7.3

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Merge OrthoPACS 8.0

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Merge Cardio 12.4

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Merge PACS 9.4

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 recall0 reports
• MIM 7.2

  Mim Software Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Focalyx Fusion 1.7

  Focalyx Technologies, LLC · System, Image Processing, Radiological
  1 recall0 reports
• SyncAR SNAP

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• SRP BrainStorm

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• SpineAR SNAP

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• SNAP OR

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• Endo SNAP

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• SRP

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• SNAP Patient Engagement PE SNAP

  Surgical Theater LLC · System, Image Processing, Radiological
  1 recall0 reports
• Simpleware ScanIP 2016.09

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Simpleware ScanIP M-2017.06

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Simpleware ScanIP N-2018.03

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Synopsys Simpleware ScanIP O-2018.12

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Synopsys Simpleware ScanIP P-2019.09

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Synopsys Simpleware ScanIP Q-2020.06

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Synopsys Simpleware ScanIP Q-2020.03

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Simpleware ScanIP Medical R-2020.09

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• Simpleware ScanIP Medical R-2021.03

  Synopsys, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• EchoNavigator EchoNavigator - 2

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  1 recall0 reports
• IntelliSpace PACS IntelliSpace PACS - 4

  Philips Healthcare Informatics, Inc. · System, image processing, radiological
  1 recall0 reports
• SmartPerfusion SmartPerfusion - 1

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  1 recall0 reports
• mintLesion® 3.4.0

  Mint Medical GmbH · System, Image Processing, Radiological
  1 recall0 reports
• mintLesion® 3.5.0

  Mint Medical GmbH · System, Image Processing, Radiological
  1 recall0 reports
• mintLesion® 3.6.0

  Mint Medical GmbH · System, Image Processing, Radiological
  1 recall0 reports
• mintLesion® 3.7.0

  Mint Medical GmbH · System, Image Processing, Radiological
  1 recall0 reports
• mintLesion™ 3.8.0

  Mint Medical GmbH · System, Image Processing, Radiological
  1 recall0 reports
• mintLesion™ 3.10.0

  Mint Medical GmbH · System, Image Processing, Radiological
  1 recall0 reports
• exoplan 3.1 Rijeka

  exocad GmbH · System, Image Processing, Radiological
  1 recall0 reports
• ImagePilot V1.92R00E

  Konica Minolta, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• ImagePilot V1.93R00E

  Konica Minolta, Inc. · System, Image Processing, Radiological
  1 recall0 reports
• nordicBrainEx 2.3

  Nordicneurolab AS · System, Image Processing, Radiological
  1 recall0 reports
• 3mensio Workstation 10.6

  Pie Medical Imaging B.V. · System, Image Processing, Radiological
  1 recall0 reports
• Change Healthcare Radiology Solutions 14.2.2

  Change Healthcare Canada Company · System, Image Processing, Radiological
  1 recall0 reports
• HeartFlow Analysis FFRct version 3

  Heartflow, Inc. · System, Image Processing, Radiological
  35 reports