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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 1
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMCG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B-SECUR , 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 2
IMEDRIX INC. (FORMERLY PIITECH INC.)
  SUBSTANTIALLY EQUIVALENT 1
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 2
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHYSIQ, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
  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
2020 59 59
2021 24 24
2022 59 59
2023 54 54
2024 63 69
2025 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 98 98
Patient Data Problem 34 34
Intermittent Communication Failure 30 30
Fire 28 28
Sparking 19 19
Computer Software Problem 9 9
Break 9 9
Insufficient Information 9 9
Detachment of Device or Device Component 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 14
Defective Device 6 6
Smoking 6 6
Battery Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Material Integrity Problem 5 5
Human-Device Interface Problem 4 4
Incorrect Interpretation of Signal 4 4
Mechanical Problem 4 4
No Display/Image 4 4
Incorrect Measurement 4 10
Data Problem 4 4
Activation, Positioning or Separation Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Display Difficult to Read 3 3
Overheating of Device 3 3
Appropriate Term/Code Not Available 3 3
Disconnection 3 3
Product Quality Problem 3 3
Computer Operating System Problem 3 3
Loose or Intermittent Connection 2 2
Electrical /Electronic Property Problem 2 2
Excessive Heating 2 2
Device Emits Odor 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Twisted/Bent 2 2
Program or Algorithm Execution Problem 2 2
Operating System Version or Upgrade Problem 2 2
High Readings 2 8
Positioning Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 2 2
Defective Component 2 2
Crack 2 2
Device Damaged Prior to Use 2 2
Application Program Problem 2 2
Unable to Obtain Readings 1 1
Leak/Splash 1 1
Air/Gas in Device 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 203 209
No Patient Involvement 43 43
Insufficient Information 28 28
No Known Impact Or Consequence To Patient 12 12
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
Myocardial Infarction 2 2
No Consequences Or Impact To Patient 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
Stroke/CVA 1 1
Death 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 Healthcare, LLC II Dec-07-2020
8 GE Medical Systems, LLC II Oct-22-2025
9 Philips North America, LLC II Jun-10-2020
10 Philips North America II Oct-16-2025
11 Schiller, Ag II Aug-27-2024
12 WELCH ALLYN, INC/MORTARA II Dec-09-2020
13 WELCH ALLYN, INC/MORTARA II Apr-29-2020
14 Welch Allyn Inc Mortara II Oct-02-2021
15 Welch Allyn Inc Mortara II Apr-22-2021
16 Withings II Mar-22-2023
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