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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 8
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANUMANA, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CARDIOCALM SRL
  SUBSTANTIALLY EQUIVALENT 2
CARDIONXT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATH VISION APS
  SUBSTANTIALLY EQUIVALENT 2
CENTERLINE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 1
IMRICOR MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K202527  Zio ECG Utilization Software (ZEUS) System
  2.  K213409  ZEUS System (Zio Watch)
  3.  K222389  ZEUS System
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 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
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 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 395 397
Display or Visual Feedback Problem 378 378
Signal Artifact/Noise 145 145
Incorrect, Inadequate or Imprecise Result or Readings 139 139
Incorrect Measurement 127 129
Failure to Transmit Record 123 123
Application Program Problem 80 80
Output Problem 69 70
Failure of Device to Self-Test 61 61
Pacing Problem 45 45
Adverse Event Without Identified Device or Use Problem 44 44
Computer Software Problem 43 43
Computer Operating System Problem 41 41
Poor Quality Image 38 38
No Display/Image 37 37
Failure to Power Up 35 35
Unexpected Shutdown 34 34
Patient Device Interaction Problem 30 30
No Apparent Adverse Event 26 26
Improper or Incorrect Procedure or Method 26 26
Connection Problem 26 26
Smoking 24 24
Impedance Problem 23 23
Electromagnetic Interference 23 24
Device Emits Odor 22 22
Electrical /Electronic Property Problem 22 22
Device Displays Incorrect Message 21 21
Erratic or Intermittent Display 19 19
Power Problem 19 19
Material Twisted/Bent 18 18
Material Integrity Problem 18 18
Inaccurate Information 18 18
Thermal Decomposition of Device 17 17
Application Program Version or Upgrade Problem 16 16
Defective Device 16 16
Electrical Shorting 15 15
Use of Device Problem 15 15
Appropriate Term/Code Not Available 15 15
Application Program Freezes, Becomes Nonfunctional 15 15
Mechanical Problem 14 14
Image Display Error/Artifact 12 12
Loose or Intermittent Connection 12 13
Noise, Audible 10 10
Tear, Rip or Hole in Device Packaging 10 10
No Device Output 10 10
Data Problem 10 10
Sparking 10 10
Overheating of Device 9 9
Nonstandard Device 9 9
Fitting Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1859 1865
Unspecified Heart Problem 130 130
Insufficient Information 46 47
Arrhythmia 22 22
Cardiac Perforation 20 20
Pericardial Effusion 8 8
No Consequences Or Impact To Patient 7 7
Skin Tears 6 6
Cardiac Arrest 6 6
Stroke/CVA 5 5
Unspecified Tissue Injury 4 4
Shock 4 4
Asystole 4 4
Atrial Fibrillation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Skin Inflammation/ Irritation 3 3
Rash 3 3
Electric Shock 3 3
Tachycardia 3 3
Heart Block 3 3
Low Blood Pressure/ Hypotension 3 3
Vascular Dissection 2 2
Diminished Pulse Pressure 2 2
Perforation 2 2
Itching Sensation 2 2
No Known Impact Or Consequence To Patient 2 2
Cardiac Tamponade 2 2
Hypersensitivity/Allergic reaction 2 2
Bradycardia 2 2
Air Embolism 2 2
Partial thickness (Second Degree) Burn 2 2
Hemorrhage/Bleeding 2 2
Atrial Flutter 2 2
Dizziness 1 1
Blister 1 1
Nausea 1 1
Failure of Implant 1 1
Needle Stick/Puncture 1 1
Ventricular Fibrillation 1 1
Oversedation 1 1
Foreign Body In Patient 1 1
Nerve Damage 1 1
Chest Pain 1 1
Pain 1 1
Cyanosis 1 1
Anaphylactic Shock 1 1
Stenosis 1 1
Syncope/Fainting 1 1
High Blood Pressure/ Hypertension 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 Jul-03-2024
11 GE Medical Systems Information Technologies Inc II Sep-19-2023
12 Merge Healthcare, Inc. II Sep-04-2025
13 Merge Healthcare, Inc. II Aug-28-2021
14 Siemens Medical Solutions USA, Inc II Jul-25-2024
15 Siemens Medical Solutions USA, Inc II Jan-09-2024
16 Siemens Medical Solutions USA, Inc II Jan-01-2023
17 Siemens Medical Solutions USA, Inc III Aug-18-2022
18 Siemens Medical Solutions USA, Inc II Jul-20-2022
19 Siemens Medical Solutions USA, Inc II Jun-06-2022
20 Siemens Medical Solutions USA, Inc II Jan-14-2022
21 Siemens Medical Solutions USA, Inc II Apr-19-2021
22 Siemens Medical Solutions USA, Inc II Mar-04-2021
23 Spacelabs Healthcare, Ltd. II Oct-31-2025
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