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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, photographic, for endoscope (exclude light sources)
Regulation Description Endoscope and accessories.
Product CodeFEM
Regulation Number 876.1500
Device Class 1

Device Problems
Break 3
Mechanical issue 2
Melted 1
Spark 1
Noise, Audible 1
Detachment of device component 1
Total Device Problems 9

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 Olympus America Inc. II Mar-05-2012

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