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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 13
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANALYTICS FOR LIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUMANA, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 2
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATH VISION APS
  SUBSTANTIALLY EQUIVALENT 2
CATHETER PRECISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERLINE BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
CORDIANA MEDICAL INFORMATICS AG
  SUBSTANTIALLY EQUIVALENT 1
CORIFY CARE S.L
  SUBSTANTIALLY EQUIVALENT 1
COROVENTIS RESEARCH AB
  SUBSTANTIALLY EQUIVALENT 2
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
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 4
MERGE HEALTHCARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MICROPACE PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  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 5

MDR Year MDR Reports MDR Events
2020 215 215
2021 351 351
2022 319 322
2023 340 343
2024 557 558
2025 440 440
2026 316 316

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 443 445
Display or Visual Feedback Problem 411 411
Incorrect Measurement 169 171
Signal Artifact/Noise 168 168
Incorrect, Inadequate or Imprecise Result or Readings 141 141
Failure to Transmit Record 120 120
Application Program Problem 87 87
Output Problem 82 83
Failure of Device to Self-Test 73 73
Adverse Event Without Identified Device or Use Problem 54 54
Computer Software Problem 53 53
Failure to Power Up 52 52
Pacing Problem 48 48
Poor Quality Image 45 45
Computer Operating System Problem 43 43
No Display/Image 32 32
Patient Device Interaction Problem 32 32
Connection Problem 30 30
Unexpected Shutdown 29 29
Image Orientation Incorrect 29 29
Device Displays Incorrect Message 28 28
Improper or Incorrect Procedure or Method 27 27
No Apparent Adverse Event 26 26
Impedance Problem 25 25
Power Problem 23 23
Electromagnetic Interference 23 24
Device Emits Odor 22 22
Appropriate Device Problem Term/Code Not Available 22 22
Material Integrity Problem 22 22
Erratic or Intermittent Display 21 21
Electrical /Electronic Property Problem 21 21
Application Program Freezes or Fails to Launch 21 21
Data Problem 20 20
Material Twisted/Bent 20 20
Thermal Decomposition of Device 19 19
Use of Device Problem 19 19
Inaccurate Information 18 18
Loose or Intermittent Connection 18 19
No Device Output 17 17
Application Program Version or Upgrade Problem 17 17
Nonstandard Device 17 17
Mechanical Problem 17 17
Electrical Shorting 16 16
Image Display Error/Artifact 16 16
Smoking 15 15
Complete Loss of Power 14 14
Sparking 13 13
Tear, Rip or Hole in Device Packaging 10 10
Fitting Problem 9 9
Overheating of Device 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2062 2068
No Consequences Or Impact To Patient 155 155
Unspecified Heart Problem 130 130
Insufficient Information 56 57
No Known Impact Or Consequence To Patient 31 31
Arrhythmia 23 23
Cardiac Perforation 22 22
Pericardial Effusion 8 8
Skin Tears 7 7
Cardiac Arrest 7 7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Stroke/CVA 5 5
No Patient Involvement 5 5
Heart Block 4 4
Electric Shock 4 4
Unspecified Tissue Injury 4 4
Shock 4 4
Asystole 4 4
Atrial Fibrillation 4 4
Low Blood Pressure/ Hypotension 3 3
Tachycardia 3 3
Skin Inflammation/ Irritation 3 3
Cardiac Tamponade 3 3
Rash 3 3
Atrial Flutter 2 2
Partial thickness (Second Degree) Burn 2 2
Reaction 2 2
Bradycardia 2 2
Pain 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Itching Sensation 2 2
Diminished Pulse Pressure 2 2
Perforation 2 2
No Information 2 2
Vascular Dissection 2 2
Complaint, Ill-Defined 2 2
Hypersensitivity/Allergic reaction 2 2
Air Embolism 2 2
Ventricular Fibrillation 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Oversedation 1 1
Unspecified Nervous System Problem 1 1
Chest Pain 1 1
Nerve Damage 1 1
Blister 1 1
Laceration(s) 1 1
Dizziness 1 1
Nausea 1 1
Anaphylactic Shock 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 Biosense Webster (israel), Ltd. II Aug-24-2020
5 Boston Scientific Corporation II Oct-16-2024
6 Boston Scientific Corporation II Apr-27-2020
7 CHANGE HEALTHCARE CANADA COMPANY II Oct-17-2024
8 CHANGE HEALTHCARE CANADA COMPANY II Apr-08-2020
9 CardioTek BV II Jun-23-2022
10 Centerline Biomedical Inc I May-19-2025
11 Edwards Lifesciences, LLC II May-08-2020
12 GE Healthcare, LLC II Apr-13-2022
13 GE Healthcare, LLC II Jun-22-2021
14 GE Medical Systems Information Technologies Inc II Jun-01-2026
15 GE Medical Systems Information Technologies Inc II Jul-03-2024
16 GE Medical Systems Information Technologies Inc II Sep-19-2023
17 Merge Healthcare, Inc. II Sep-04-2025
18 Merge Healthcare, Inc. II Aug-28-2021
19 Siemens Medical Solutions USA, Inc II Jul-25-2024
20 Siemens Medical Solutions USA, Inc II Jan-09-2024
21 Siemens Medical Solutions USA, Inc II Jan-01-2023
22 Siemens Medical Solutions USA, Inc III Aug-18-2022
23 Siemens Medical Solutions USA, Inc II Jul-20-2022
24 Siemens Medical Solutions USA, Inc II Jun-06-2022
25 Siemens Medical Solutions USA, Inc II Jan-14-2022
26 Siemens Medical Solutions USA, Inc II Apr-19-2021
27 Siemens Medical Solutions USA, Inc II Mar-04-2021
28 Siemens Medical Solutions USA, Inc II Aug-28-2020
29 Spacelabs Healthcare, Ltd. II Oct-31-2025
30 Spacelabs Healthcare, Ltd. II Dec-10-2020
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