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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
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 3
GENETESIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 27 27
2020 59 59
2021 24 24
2022 59 59
2023 54 54
2024 63 69
2025 57 57
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 99 99
Patient Data Problem 34 34
Intermittent Communication Failure 30 30
Fire 30 30
Sparking 19 19
Unable to Obtain Readings 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 17
Computer Software Problem 10 10
Break 9 9
Insufficient Information 9 9
Detachment of Device or Device Component 8 8
Smoking 7 7
Incorrect Measurement 6 12
Therapeutic or Diagnostic Output Failure 6 6
Defective Device 6 6
No Display/Image 5 5
Battery Problem 5 5
Material Integrity Problem 5 5
Human-Device Interface Problem 4 4
Activation, Positioning or Separation Problem 4 4
Incorrect Interpretation of Signal 4 4
Mechanical Problem 4 4
Data Problem 4 4
Computer Operating System Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Overheating of Device 3 3
Connection Problem 3 3
Appropriate Term/Code Not Available 3 3
Product Quality Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Disconnection 3 3
Application Program Problem 3 3
Display Difficult to Read 3 3
Output Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Defective Component 2 2
Positioning Problem 2 2
High Readings 2 8
Operating System Version or Upgrade Problem 2 2
Loose or Intermittent Connection 2 2
Electrical /Electronic Property Problem 2 2
Program or Algorithm Execution Problem 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Device Damaged Prior to Use 2 2
Image Display Error/Artifact 2 2
Crack 2 2
Device Emits Odor 2 2
Excessive Heating 2 2
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 206 212
No Patient Involvement 50 50
Insufficient Information 28 28
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 6 6
Electric Shock 5 5
Superficial (First Degree) Burn 4 4
Death 4 4
Asystole 4 4
Myocardial Infarction 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body Sensation in Eye 1 1
Syncope/Fainting 1 1
Stroke/CVA 1 1
Hypersensitivity/Allergic reaction 1 1
Shock from Patient Lead(s) 1 1
Dizziness 1 1
Ischemia 1 1
Complete Heart Block 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, LLC II Feb-21-2019
11 Philips North America II Oct-16-2025
12 Schiller, Ag II Aug-27-2024
13 WELCH ALLYN, INC/MORTARA II Dec-09-2020
14 WELCH ALLYN, INC/MORTARA II Apr-29-2020
15 Welch Allyn Inc Mortara II Oct-02-2021
16 Welch Allyn Inc Mortara II Apr-22-2021
17 Withings II Mar-22-2023
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