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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, environmental control, powered
Regulation Description Powered environmental control system.
Product CodeIQA
Regulation Number 890.3725
Device Class 2


Premarket Reviews
ManufacturerDecision
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device alarm system issue 1
Use of Device Issue 1
Low battery 1
Total Device Problems 3

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 0 1 0 0 0
Class III 0 0 0 0 0 2 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Intel-GE Care Innovations LLC II May-24-2013
2 Intel-GE Care Innovations LLC III Jun-05-2012
3 Intel-GE Care Innovations LLC III May-16-2012

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