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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device table, radiologic
Regulation Description Radiologic table.
Product CodeKXJ
Regulation Number 892.1980
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1
WU'S
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 4
Fracture 2
Slippage of device or device component 2
System fails to activate 2
Device inoperable 2
Locking mechanism failure 1
Detachment of device or device component 1
Unintended movement 1
Computer failure 1
Failure, intermittent 1
Total Device Problems 17

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

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Nov-08-2007
2 Maquet Inc. II May-23-2011
3 Villa Radiology Systems LLC II Mar-06-2015
4 Villa Radiology Systems LLC II Sep-13-2013

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