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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computer, diagnostic, programmable
Regulation Description Programmable diagnostic computer.
Product CodeDQK
Regulation Number 870.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANALYTICS FOR LIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUMANA, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 2
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATH VISION APS
  SUBSTANTIALLY EQUIVALENT 2
CENTERLINE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
CORIFY CARE S.L
  SUBSTANTIALLY EQUIVALENT 1
COROVENTIS RESEARCH AB
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFECIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 8
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMPLICITY, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMRICOR MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
IMRICOR MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ITAMAR MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARDIUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
MERGE HEALTHCARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MICROPACE PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. (PMSN)
  SUBSTANTIALLY EQUIVALENT 1
PHYSCADE, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIPU S.R.L
  SUBSTANTIALLY EQUIVALENT 1
RHYTHM AI, LTD.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHM AL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFEBEAT RX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNERGEN TECHNOLOGY LABS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VEKTOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VITALCONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 351 351
2022 319 322
2023 340 343
2024 557 558
2025 440 440
2026 368 368

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 431 433
Display or Visual Feedback Problem 395 395
Signal Artifact/Noise 168 168
Incorrect Measurement 159 161
Incorrect, Inadequate or Imprecise Result or Readings 144 144
Failure to Transmit Record 120 120
Application Program Problem 82 82
Output Problem 73 74
Failure of Device to Self-Test 67 67
Adverse Event Without Identified Device or Use Problem 52 52
Computer Software Problem 47 47
Pacing Problem 46 46
Poor Quality Image 45 45
Failure to Power Up 43 43
Computer Operating System Problem 42 42
Patient Device Interaction Problem 32 32
Connection Problem 30 30
No Display/Image 29 29
No Apparent Adverse Event 29 29
Unexpected Shutdown 26 26
Improper or Incorrect Procedure or Method 26 26
Device Displays Incorrect Message 26 26
Power Problem 24 24
Impedance Problem 24 24
Electromagnetic Interference 23 24
Nonstandard Device 22 22
Device Emits Odor 22 22
Erratic or Intermittent Display 21 21
Electrical /Electronic Property Problem 21 21
Application Program Freezes or Fails to Launch 21 21
Material Integrity Problem 20 20
Data Problem 19 19
Material Twisted/Bent 19 19
Inaccurate Information 18 18
Thermal Decomposition of Device 18 18
Appropriate Device Problem Term/Code Not Available 17 17
Application Program Version or Upgrade Problem 17 17
Mechanical Problem 16 16
Image Display Error/Artifact 16 16
Electrical Shorting 16 16
Loose or Intermittent Connection 15 16
Smoking 15 15
Complete Loss of Power 14 14
Use of Device Problem 14 14
Tear, Rip or Hole in Device Packaging 10 10
Sparking 10 10
No Device Output 10 10
Overheating of Device 9 9
Device Sensing Problem 8 8
No Pacing 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2074 2080
Unspecified Heart Problem 130 130
Insufficient Information 53 54
Arrhythmia 22 22
Cardiac Perforation 20 20
Pericardial Effusion 8 8
No Consequences Or Impact To Patient 7 7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 6 6
Skin Tears 6 6
Cardiac Arrest 6 6
Stroke/CVA 5 5
Unspecified Tissue Injury 4 4
Atrial Fibrillation 4 4
Shock 4 4
Asystole 4 4
Low Blood Pressure/ Hypotension 3 3
Heart Block 3 3
Electric Shock 3 3
Skin Inflammation/ Irritation 3 3
Tachycardia 3 3
Rash 3 3
Atrial Flutter 2 2
Partial thickness (Second Degree) Burn 2 2
Stenosis 2 2
Bradycardia 2 2
Pain 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
No Known Impact Or Consequence To Patient 2 2
Cardiac Tamponade 2 2
Itching Sensation 2 2
Diminished Pulse Pressure 2 2
Perforation 2 2
Vascular Dissection 2 2
Hypersensitivity/Allergic reaction 2 2
High Blood Pressure/ Hypertension 2 2
Air Embolism 2 2
Ventricular Fibrillation 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Oversedation 1 1
Chest Pain 1 1
Nerve Damage 1 1
Pulmonary Valve Stenosis 1 1
Unspecified Nervous System Problem 1 1
Laceration(s) 1 1
Blister 1 1
Dizziness 1 1
Anaphylactic Shock 1 1
Nausea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 APN Health LLC III Dec-14-2023
2 Abbott Laboratories Inc. (St Jude Medical) II Jun-14-2021
3 Baxter Healthcare Corporation II Sep-28-2023
4 Boston Scientific Corporation II Oct-16-2024
5 CHANGE HEALTHCARE CANADA COMPANY II Oct-17-2024
6 CardioTek BV II Jun-23-2022
7 Centerline Biomedical Inc I May-19-2025
8 GE Healthcare, LLC II Apr-13-2022
9 GE Healthcare, LLC II Jun-22-2021
10 GE Medical Systems Information Technologies Inc II Jun-01-2026
11 GE Medical Systems Information Technologies Inc II Jul-03-2024
12 GE Medical Systems Information Technologies Inc II Sep-19-2023
13 Merge Healthcare, Inc. II Sep-04-2025
14 Merge Healthcare, Inc. II Aug-28-2021
15 Siemens Medical Solutions USA, Inc II Jul-25-2024
16 Siemens Medical Solutions USA, Inc II Jan-09-2024
17 Siemens Medical Solutions USA, Inc II Jan-01-2023
18 Siemens Medical Solutions USA, Inc III Aug-18-2022
19 Siemens Medical Solutions USA, Inc II Jul-20-2022
20 Siemens Medical Solutions USA, Inc II Jun-06-2022
21 Siemens Medical Solutions USA, Inc II Jan-14-2022
22 Siemens Medical Solutions USA, Inc II Apr-19-2021
23 Siemens Medical Solutions USA, Inc II Mar-04-2021
24 Spacelabs Healthcare, Ltd. II Oct-31-2025
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