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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 11
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANUMANA, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 6
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, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORDIANA MEDICAL INFORMATICS AG
  SUBSTANTIALLY EQUIVALENT 1
COROVENTIS RESEARCH AB
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFECIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 7
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 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
PHILIPS MEDICAL SYSTEM NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  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 1
RHYTHM AL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE, LTD.
  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 402 402

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 382 384
Display or Visual Feedback Problem 378 378
Signal Artifact/Noise 148 148
Incorrect, Inadequate or Imprecise Result or Readings 127 127
Incorrect Measurement 125 127
Failure to Transmit Record 124 124
Application Program Problem 80 80
Output Problem 76 77
Failure of Device to Self-Test 61 61
Computer Software Problem 45 45
Adverse Event Without Identified Device or Use Problem 45 45
Pacing Problem 43 43
Failure to Power Up 43 43
Computer Operating System Problem 38 38
No Display/Image 38 38
Unexpected Shutdown 36 36
Poor Quality Image 30 30
Patient Device Interaction Problem 30 30
Image Orientation Incorrect 29 29
Improper or Incorrect Procedure or Method 27 27
No Apparent Adverse Event 25 25
Connection Problem 23 23
Smoking 23 23
Electrical /Electronic Property Problem 22 22
Device Emits Odor 22 22
Impedance Problem 22 22
Appropriate Term/Code Not Available 21 21
Use of Device Problem 21 21
Device Displays Incorrect Message 20 20
Electromagnetic Interference 20 21
Material Twisted/Bent 19 19
Material Integrity Problem 19 19
Inaccurate Information 18 18
Thermal Decomposition of Device 18 18
Power Problem 17 17
Erratic or Intermittent Display 17 17
No Device Output 16 16
Application Program Version or Upgrade Problem 16 16
Loose or Intermittent Connection 15 16
Defective Device 15 15
Electrical Shorting 15 15
Patient Data Problem 14 14
Data Problem 13 13
Mechanical Problem 13 13
Noise, Audible 12 12
Sparking 12 12
Tear, Rip or Hole in Device Packaging 10 10
Insufficient Information 9 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 1725 1731
No Consequences Or Impact To Patient 155 155
Unspecified Heart Problem 130 130
Insufficient Information 48 49
No Known Impact Or Consequence To Patient 31 31
Arrhythmia 22 22
Cardiac Perforation 22 22
Pericardial Effusion 8 8
Skin Tears 7 7
Cardiac Arrest 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Stroke/CVA 5 5
No Patient Involvement 5 5
Heart Block 4 4
Shock 4 4
Electric Shock 4 4
Asystole 4 4
Atrial Fibrillation 4 4
Tachycardia 3 3
Cardiac Tamponade 3 3
Perforation 2 2
Diminished Pulse Pressure 2 2
Vascular Dissection 2 2
Skin Inflammation/ Irritation 2 2
Rash 2 2
No Information 2 2
Reaction 2 2
Bradycardia 2 2
Complaint, Ill-Defined 2 2
Air Embolism 2 2
Partial thickness (Second Degree) Burn 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Atrial Flutter 2 2
Itching Sensation 1 1
Dizziness 1 1
Needle Stick/Puncture 1 1
Ventricular Fibrillation 1 1
Oversedation 1 1
Foreign Body In Patient 1 1
Nausea 1 1
Nerve Damage 1 1
Chest Pain 1 1
Failure of Implant 1 1
Hypersensitivity/Allergic reaction 1 1
Anaphylactic Shock 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Death 1 1
Syncope/Fainting 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 Jul-03-2024
15 GE Medical Systems Information Technologies Inc II Sep-19-2023
16 Merge Healthcare, Inc. II Sep-04-2025
17 Merge Healthcare, Inc. II Aug-28-2021
18 Siemens Medical Solutions USA, Inc II Jul-25-2024
19 Siemens Medical Solutions USA, Inc II Jan-09-2024
20 Siemens Medical Solutions USA, Inc II Jan-01-2023
21 Siemens Medical Solutions USA, Inc III Aug-18-2022
22 Siemens Medical Solutions USA, Inc II Jul-20-2022
23 Siemens Medical Solutions USA, Inc II Jun-06-2022
24 Siemens Medical Solutions USA, Inc II Jan-14-2022
25 Siemens Medical Solutions USA, Inc II Apr-19-2021
26 Siemens Medical Solutions USA, Inc II Mar-04-2021
27 Siemens Medical Solutions USA, Inc II Aug-28-2020
28 Spacelabs Healthcare, Ltd. II Oct-31-2025
29 Spacelabs Healthcare, Ltd. II Dec-10-2020
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