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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
Break 9 9
Computer Software Problem 9 9
Insufficient Information 9 9
Incorrect, Inadequate or Imprecise Result or Readings 8 14
Detachment of Device or Device Component 8 8
Smoking 6 6
Defective Device 6 6
Material Integrity Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Battery Problem 5 5
Incorrect Interpretation of Signal 4 4
Activation, Positioning or Separation Problem 4 4
Mechanical Problem 4 4
Human-Device Interface Problem 4 4
Incorrect Measurement 4 10
Data Problem 4 4
No Display/Image 4 4
Computer Operating System Problem 3 3
Display Difficult to Read 3 3
Disconnection 3 3
Appropriate Term/Code Not Available 3 3
Overheating of Device 3 3
Product Quality Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Excessive Heating 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 2 2
Material Twisted/Bent 2 2
Application Program Problem 2 2
Electrical /Electronic Property Problem 2 2
Crack 2 2
Defective Component 2 2
Operating System Version or Upgrade Problem 2 2
High Readings 2 8
Device Damaged Prior to Use 2 2
Program or Algorithm Execution Problem 2 2
Output Problem 2 2
Device Emits Odor 2 2
Loose or Intermittent Connection 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Capture 1 1
Air/Gas in Device 1 1
Use of Device Problem 1 1
Temperature Problem 1 1
Compatibility 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
Electric Shock 4 4
Asystole 4 4
Superficial (First Degree) Burn 4 4
Cardiac Arrest 3 3
Burn(s) 2 2
Myocardial Infarction 2 2
Burning Sensation 2 2
Atrial Fibrillation 2 2
Arrhythmia 2 2
Chest Pain 2 2
No Consequences Or Impact To Patient 2 2
Eye Pain 2 2
Hypersensitivity/Allergic reaction 1 1
Abrasion 1 1
Shock from Patient Lead(s) 1 1
Exposure to Body Fluids 1 1
Swelling/ Edema 1 1
Stroke/CVA 1 1
Pain 1 1
Eye Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Erythema 1 1
Heart Block 1 1
Foreign Body Sensation in Eye 1 1
Myocarditis 1 1
Ventricular Fibrillation 1 1
Syncope/Fainting 1 1
Dizziness 1 1
Discomfort 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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