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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 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 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 1
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 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 87 87
Patient Data Problem 32 32
Intermittent Communication Failure 29 29
Fire 28 28
Sparking 19 19
Break 9 9
Detachment of Device or Device Component 8 8
Insufficient Information 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 13
Defective Device 6 6
Smoking 6 6
Battery Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Material Integrity Problem 5 5
Incorrect Interpretation of Signal 4 4
Incorrect Measurement 4 10
Data Problem 4 4
Mechanical Problem 4 4
No Display/Image 4 4
Activation, Positioning or Separation Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Display Difficult to Read 3 3
Appropriate Term/Code Not Available 3 3
Computer Software Problem 3 3
Computer Operating System Problem 3 3
Product Quality Problem 3 3
Application Program Problem 2 2
Defective Component 2 2
Device Damaged Prior to Use 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Positioning Problem 2 2
Crack 2 2
Output Problem 2 2
Loose or Intermittent Connection 2 2
High Readings 2 8
Operating System Version or Upgrade Problem 2 2
Electrical /Electronic Property Problem 2 2
Program or Algorithm Execution Problem 2 2
Disconnection 2 2
Excessive Heating 2 2
Material Twisted/Bent 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Emits Odor 2 2
Temperature Problem 1 1
Signal Artifact/Noise 1 1
Capturing Problem 1 1
Connection Problem 1 1
Unexpected Therapeutic Results 1 1
Protective Measures Problem 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 186 192
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 3 3
Cardiac Arrest 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body Sensation in Eye 1 1
Syncope/Fainting 1 1
Death 1 1
Stroke/CVA 1 1
Hypersensitivity/Allergic reaction 1 1
Arrhythmia 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

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 Philips North America, LLC II Jun-10-2020
9 Schiller, Ag II Aug-27-2024
10 WELCH ALLYN, INC/MORTARA II Dec-09-2020
11 WELCH ALLYN, INC/MORTARA II Apr-29-2020
12 Welch Allyn Inc Mortara II Oct-02-2021
13 Welch Allyn Inc Mortara II Apr-22-2021
14 Withings II Mar-22-2023
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