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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, electrocardiograph
Regulation Description Electrocardiograph electrode.
Product CodeDRX
Regulation Number 870.2360
Device Class 2


Premarket Reviews
ManufacturerDecision
HMICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 66
Adverse Event Without Identified Device or Use Problem 29
Improper or Incorrect Procedure or Method 10
No Display / Image 7
Appropriate Term/Code Not Available 6
Missing Value Reason 6
No Apparent Adverse Event 4
Unable to Obtain Readings 3
Device Handling Problem 2
Patient Device Interaction Problem 2
Failure to Read Input Signal 2
Electrical Power Problem 1
Detachment Of Device Component 1
Failure To Adhere Or Bond 1
Device Operates Differently Than Expected 1
Device Contamination with Chemical or Other Material 1
Device Appears to Trigger Rejection 1
Device Sensing Problem 1
Incorrect Interpretation of signal 1
Device Displays Incorrect Message 1
Device-Device Incompatibility 1
Missing Information 1
Thermal Decomposition of Device 1
Gel Leak 1
Sparking 1
Total Device Problems 151

Recalls
Manufacturer Recall Class Date Posted
1 Leonhard Lang Medizintechnik GmbH II Nov-18-2015
2 Leonhard Lang Medizintechnik GmbH II Mar-28-2015

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