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TPLC
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show TPLC since
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Device
electrocardiograph
Product Code
DPS
Regulation Number
870.2340
Device Class
2
Premarket Reviews
Manufacturer
Decision
B-SECUR LTD.
SUBSTANTIALLY EQUIVALENT
1
BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BIONET CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
CAF MEDICAL SOLUTIONS INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIACSENSE
SUBSTANTIALLY EQUIVALENT
1
CARDIO-PHOENIX INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOLOGS TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
COALA LIFE AB
SUBSTANTIALLY EQUIVALENT
1
CONTEC MEDICAL SYSTEMS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
CORSCIENCE GMBH & CO.
SUBSTANTIALLY EQUIVALENT
1
DAILYCARE BIOMEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
2
FUKUDA DENSHI USA, INC.
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
MEDICAL PREDICTIVE SCIENCE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDIZIN SYSTEME BOBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
MITAC INTERNATIONAL CORP.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
PHYSIQ INC.
SUBSTANTIALLY EQUIVALENT
1
PHYSIQ, INC
SUBSTANTIALLY EQUIVALENT
2
SAMSUNG STRATEGY AND INNOVATION CENTER (SSIC)
SUBSTANTIALLY EQUIVALENT
1
SCHILLER AG
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN CAREWELL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SUZUKEN CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
VECTRACOR, INC.
SUBSTANTIALLY EQUIVALENT
1
WITHINGS SA
SUBSTANTIALLY EQUIVALENT
1
ZOLL MANUFACTURING CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
19
19
2019
27
27
2020
59
59
2021
24
24
2022
59
59
2023
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Wireless Communication Problem
52
52
Intermittent Communication Failure
26
26
Unable to Obtain Readings
16
16
Fire
15
15
Patient Data Problem
13
13
No Display/Image
7
7
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Smoking
5
5
Sparking
5
5
Insufficient Information
5
5
Therapeutic or Diagnostic Output Failure
4
4
Computer Operating System Problem
4
4
Connection Problem
4
4
Data Problem
4
4
Detachment of Device or Device Component
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Output Problem
3
3
Mechanical Problem
3
3
Break
3
3
Display Difficult to Read
3
3
Disconnection
2
2
Thermal Decomposition of Device
2
2
Device Emits Odor
2
2
Image Display Error/Artifact
2
2
Improper or Incorrect Procedure or Method
2
2
Defective Component
2
2
Incorrect Measurement
2
2
Application Program Problem
2
2
Battery Problem
2
2
Program or Algorithm Execution Problem
2
2
Patient Device Interaction Problem
1
1
Explosion
1
1
Unexpected Shutdown
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Capturing Problem
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Power Problem
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
Device Operates Differently Than Expected
1
1
Compatibility Problem
1
1
Inappropriate Waveform
1
1
Defective Device
1
1
Device Displays Incorrect Message
1
1
Device Damaged Prior to Use
1
1
Malposition of Device
1
1
Device Stops Intermittently
1
1
Unexpected Therapeutic Results
1
1
Use of Device Problem
1
1
Material Rupture
1
1
Self-Activation or Keying
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Failure to Read Input Signal
1
1
Labelling, Instructions for Use or Training Problem
1
1
Electrical /Electronic Property Problem
1
1
No Device Output
1
1
Failure to Power Up
1
1
Product Quality Problem
1
1
Failure to Capture
1
1
Computer Software Problem
1
1
Crack
1
1
Device Alarm System
1
1
Signal Artifact/Noise
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
81
81
No Patient Involvement
56
56
No Known Impact Or Consequence To Patient
31
31
Insufficient Information
11
11
No Consequences Or Impact To Patient
9
9
Death
4
4
Myocardial Infarction
4
4
Electric Shock
3
3
Burn(s)
3
3
Cardiac Arrest
2
2
Ventricular Fibrillation
1
1
Shock from Patient Lead(s)
1
1
Hypersensitivity/Allergic reaction
1
1
Complete Heart Block
1
1
Stroke/CVA
1
1
Ischemia
1
1
Burning Sensation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Jan-24-2023
2
GE Healthcare, LLC
II
Dec-07-2020
3
Philips North America, LLC
II
Jun-10-2020
4
Philips North America, LLC
II
Feb-21-2019
5
WELCH ALLYN, INC/MORTARA
II
Dec-09-2020
6
WELCH ALLYN, INC/MORTARA
II
Apr-29-2020
7
Welch Allyn Inc Mortara
II
Oct-02-2021
8
Welch Allyn Inc Mortara
II
Apr-22-2021
9
Withings
II
Mar-22-2023
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