Computer, diagnostic, programmable

FDA product code DQK · Class 2 · 142 devices · 2,021 reports · 19 deaths reported · 38 devices named in recalls

• ZIO AT Patch A100A100X

  Irhythm Technologies, Inc. · Computer, Diagnostic, Programmable
  1 recall14 deaths629 reports
• CARTO 3 FG540000

  Biosense Webster (Israel) Ltd. · Computer, diagnostic, programmable
  1 death437 reports
• Sensis 10764561

  Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  5 recalls8 reports
• Sensis Vibe Hemo 11007641

  Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  4 recalls1 death22 reports
• Sensis Vibe Combo 11007642

  Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  4 recalls1 death6 reports
• Change Healthcare Cardiology Hemo 15.1

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  4 recalls1 report
• Change Healthcare Cardiology Hemo 15.0.1

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  3 recalls1 death1 report
• CARESCAPE CENTRAL STATION MAI800

  Ge Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable
  3 recalls0 reports
• Change Healthcare Cardiology Hemo 14.3.2

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  3 recalls0 reports
• EnSite™ ENSITE-AMP-02

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  106 reports
• CARESCAPE CENTRAL STATION MAI800

  Ge Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable
  2 recalls1 death1 report
• CardioLab AltiX

  Ge Medical Systems Information Technologies, Inc. · Computer, diagnostic, programmable
  2 recalls0 reports
• ComboLab AltiX

  Ge Medical Systems Information Technologies, Inc. · Computer, diagnostic, programmable
  2 recalls0 reports
• NA B125P VSP3.0 Patient Monitor

  GE Medical Systems Information Technologies, Inc. · Computer, diagnostic, programmable
  2 recalls0 reports
• Change Healthcare Cardiology Hemo 14.3

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  2 recalls0 reports
• McKesson Cardiology Hemo 13.2.1

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  2 recalls0 reports
• EnSite™ Velocity™ 100014514

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  87 reports
• WorkMate Claris™ H700150

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  72 reports
• Merge Hemo 10.4

  Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable
  1 recall14 reports
• AVVIGO™+ H7492493120I0

  Boston Scientific Corporation · Computer, diagnostic, programmable
  1 recall4 reports
• Merge Hemo 10.2

  Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable
  1 recall3 reports
• IOPS™ ATW-2

  Centerline Biomedical, Inc. · Computer, Diagnostic, Programmable
  1 recall3 reports
• Xper Information Management System 5

  Philips Medical Systems Nederland B.V. · Computer, diagnostic, programmable
  1 recall2 reports
• FORESIGHT OXIMETER CABLE HEMFSM10

  Edwards Lifesciences LLC · Computer, Diagnostic, Programmable
  1 recall1 report
• Merge Hemo 10.3

  Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable
  1 recall1 report
• AVVIGO™+ H7492493120D0

  Boston Scientific Corporation · Computer, diagnostic, programmable
  1 recall0 reports
• MAC 5 A5

  Ge Medical Systems Information Technologies, Inc. · Computer, diagnostic, programmable
  1 recall0 reports
• CARESCAPE ONE MBZ323

  Ge Medical Systems Information Technologies, Inc. · Computer, diagnostic, programmable
  1 recall0 reports
• CASE V7.0

  GE Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable
  1 recall0 reports
• Vision Express BURV53H-0

  Mortara Instrument, Inc. · Computer, Diagnostic, Programmable
  1 recall0 reports
• Vision Express BURV53H-1

  Mortara Instrument, Inc. · Computer, Diagnostic, Programmable
  1 recall0 reports
• Vision Express BURV53H-2

  Mortara Instrument, Inc. · Computer, Diagnostic, Programmable
  1 recall0 reports
• Vision Express BURV53H-5

  Mortara Instrument, Inc. · Computer, Diagnostic, Programmable
  1 recall0 reports
• MUSE NX

  GE Medical Systems Information Technologies, Inc. · Computer, diagnostic, programmable
  1 recall0 reports
• Cardio Server 6.1

  Epiphany Healthcare Data Management, LLC · Computer, Diagnostic, Programmable
  1 recall0 reports
• Cardio Server 6.2

  Epiphany Healthcare Data Management, LLC · Computer, Diagnostic, Programmable
  1 recall0 reports
• Cardio Server 7.0

  Epiphany Healthcare Data Management, LLC · Computer, Diagnostic, Programmable
  1 recall0 reports
• Navik 3D Navik 3D v2.0

  Apn Health · Computer, Diagnostic, Programmable
  1 recall0 reports
• EP-TRACER 40SYS01

  CardioTek B.V. · Computer, Diagnostic, Programmable
  1 recall0 reports
• Intesys® Clinical Suite Smart Disclosure

  Spacelabs Healthcare (Washington), Inc · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 recall0 reports
• Sentinel Sentinel 11

  Spacelabs Healthcare (Washington), Inc · Computer, diagnostic, programmable
  1 recall0 reports
• Change Healthcare Cardiology Hemo 15.0

  Change Healthcare Canada Company · Computer, Diagnostic, Programmable
  1 recall0 reports
• WorkMate Claris™ H700977

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  45 reports
• EnSite™ ENSITE-R-AMP-02

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  38 reports
• WorkMate Claris™ H700169

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  37 reports
• EnSite™ ENSITE-DWS-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  34 reports
• HemoSphere HEMCSM10

  Edwards Lifesciences LLC · Computer, Diagnostic, Programmable
  29 reports
• WorkMate Claris™ H700124

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  26 reports
• Smart Pressure Controller PC1Q

  Edwards Lifesciences LLC · Computer, Diagnostic, Programmable
  21 reports
• EnSite™ EE3000

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  21 reports
• Zio ECG Utilization Software (ZEUS) System FG0401US

  Irhythm Technologies, Inc. · Computer, Diagnostic, Programmable
  20 reports
• Philips 860343

  Philips Medical Systems Hsg · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  18 reports
• EnSite™ ENSITE-DWS-1.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  17 reports
• EnSite Precision™ Link, Sensor Enabled™ H702475

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  16 reports
• EP-WorkMate™ 100019209

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  14 reports
• WorkMate Claris™ H700123

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  12 reports
• NA H749A70200

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  12 reports
• Merge Hemo 10.0.4

  Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable
  11 reports
• iLab Ultrasound Imaging System H749ILAB220CART0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  11 reports
• QUANTIEN™ Measurement System

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  10 reports
• EnSite™ ENSITE-FF-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  10 reports
• EnSite™ ENSITE-SRFLNK-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  10 reports
• EnSite™ ENSITE-SYSTEM-111

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  10 reports
• LABSYSTEM™ PRO M00420020340

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  10 reports
• Stress ST80i Stress Test System

  Philips Medical Systems Hsg · Computer, diagnostic, programmable
  9 reports
• EnSite™ ENSITE-SEK-5-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  8 reports
• EnSite™ ENSITE-DWS-2.0.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  8 reports
• EnSite™ ENSITE-DWS-04

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  8 reports
• EnSite Precision™ EN0020-P

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  7 reports
• RHYTHMIA HDx™ M004RH10200

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  7 reports
• FFR Link H7495551000

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  6 reports
• Affera™ Mapping System AFR-00003

  Medtronic, Inc. · Computer, diagnostic, programmable
  5 reports
• EnSite™ Velocity NavLink

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  5 reports
• EP-WorkMate™ System

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  5 reports
• EnSite™ ENSITE-SW-3.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  5 reports
• iLab™ Polaris Multi-Modality Guidance System H74939322120C0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  5 reports
• VitaWave VWCA2

  Edwards Lifesciences LLC · Computer, Diagnostic, Programmable
  4 reports
• Merge HEMO 10.1

  Merge Healthcare Solutions Inc. · Computer, Diagnostic, Programmable
  4 reports
• EP-WorkMate™ Recording System

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  4 reports
• iLab Ultrasound Imaging System H749ILAB100CART0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  4 reports
• OPAL HDx™ M004OPLINSTALL2EN0

  Boston Scientific Corporation · Computer, diagnostic, programmable
  3 reports
• ACUMEN IQ AIQFM10

  Edwards Lifesciences LLC · Computer, Diagnostic, Programmable
  3 reports
• WorkMate™ H700088

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  3 reports
• EnSite™ ENSITE-AMP-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  3 reports
• EnSite™ ENSITE-SW-3.1.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  3 reports
• iLab Ultrasound Imaging System H749ILAB240CART0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  3 reports
• iLab Ultrasound Imaging System H749ILAB120CART0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  3 reports
• RHYTHMIA HDx™ M004RBINSTALL2EN0

  Boston Scientific Corporation · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  3 reports
• SWAN-GANZ HEMA70CC2

  Edwards Lifesciences LLC · Computer, Diagnostic, Programmable
  2 reports
• IECG B.01.00

  Philips Medical Systems Hsg · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• EnSite™ NavX™ EN0010-100003331

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• EnSite™ EE3000

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• WorkMate Claris™ H701703

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• EnSite Precision™ H702470

  St. Jude Medical, Inc. · COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• EnSite™ ENSITE-FF-4.5C-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-PRSFRNT-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-ACBL-60-01

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-2.0.1

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-03

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports
• EnSite™ ENSITE-SW-3.0.2

  St. Jude Medical, Inc. · Computer, diagnostic, programmable
  2 reports