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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, circular (spiral), scalp and applicator
Regulation Description Fetal scalp circular (spiral) electrode and applicator.
Product CodeHGP
Regulation Number 884.2675
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device, removal of (non-implant) 10
Device operates differently than expected 4
Foreign material present in device 1
No Known Device Problem 1
Failure to capture 1
Entrapment of device or device component 1
Unable to obtain readings 1
Failure to read input signal 1
Transmitter failure 1
Improper or incorrect procedure or method 1
Device Issue 1
Total Device Problems 23

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Vital Signs Devices, a GE Healthcare Company II Nov-16-2012

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