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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrocardiograph
Regulation Description Electrocardiograph.
Product CodeDPS
Regulation Number 870.2340
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURKARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
CAF MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIACSENSE
  SUBSTANTIALLY EQUIVALENT 2
CARDIOLOGS TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COALA LIFE AB
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EKGENIUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
INMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MEDIBLU MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDIZIN SYSTEME BOBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD.; MESI D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS FRANCE COMMERCIAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRISMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS
  SUBSTANTIALLY EQUIVALENT 2
WITHINGS SA
  SUBSTANTIALLY EQUIVALENT 1
ZBEATS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 24 24
2022 59 59
2023 54 54
2024 63 69
2025 57 57
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 63 63
Patient Data Problem 32 32
Intermittent Communication Failure 30 30
Fire 25 25
Sparking 18 18
Incorrect Measurement 11 17
High Readings 10 16
Computer Software Problem 9 9
Insufficient Information 9 9
Detachment of Device or Device Component 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 14
Break 7 7
Defective Device 5 5
Battery Problem 5 5
Material Integrity Problem 5 5
Human-Device Interface Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Activation, Positioning or Separation Problem 4 4
Incorrect Interpretation of Signal 4 4
Smoking 4 4
Mechanical Problem 4 4
Overheating of Device 3 3
Disconnection 3 3
Display Difficult to Read 3 3
Improper or Incorrect Procedure or Method 3 3
Product Quality Problem 3 3
Appropriate Term/Code Not Available 3 3
Data Problem 2 2
Operating System Version or Upgrade Problem 2 2
Output Problem 2 2
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Twisted/Bent 2 2
Application Program Problem 2 2
Excessive Heating 2 2
Program or Algorithm Execution Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
No Display/Image 2 2
Electrical /Electronic Property Problem 2 2
Crack 2 2
Loose or Intermittent Connection 2 2
Inability to Auto-Fill 1 1
Material Frayed 1 1
Leak/Splash 1 1
Failure to Power Up 1 1
Device Difficult to Program or Calibrate 1 1
Device Emits Odor 1 1
Thermal Decomposition of Device 1 1
Failure to Capture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 218 224
Insufficient Information 26 26
No Patient Involvement 6 6
Superficial (First Degree) Burn 4 4
Electric Shock 4 4
Asystole 4 4
Cardiac Arrest 3 3
Arrhythmia 2 2
Atrial Fibrillation 2 2
Burn(s) 2 2
Burning Sensation 2 2
Chest Pain 2 2
Eye Pain 2 2
Foreign Body Sensation in Eye 1 1
Syncope/Fainting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Shock from Patient Lead(s) 1 1
Dizziness 1 1
Abrasion 1 1
Myocarditis 1 1
Ventricular Fibrillation 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Discomfort 1 1
Pain 1 1
Eye Injury 1 1
Swelling/ Edema 1 1
Heart Block 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-14-2025
2 Baxter Healthcare Corporation II Nov-07-2024
3 Baxter Healthcare Corporation II Jul-10-2024
4 Baxter Healthcare Corporation II Jan-10-2024
5 Baxter Healthcare Corporation II Jan-24-2023
6 Braemar Manufacturing, LLC I Dec-23-2024
7 GE Medical Systems, LLC II Oct-22-2025
8 Philips North America II Oct-16-2025
9 Schiller, Ag II Aug-27-2024
10 Welch Allyn Inc Mortara II Oct-02-2021
11 Welch Allyn Inc Mortara II Apr-22-2021
12 Withings II Mar-22-2023
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