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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microscope, surgical, general & plastic surgery
Regulation Description Surgical microscope and accessories.
Product CodeFSO
Regulation Number 878.4700
Device Class 1


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
ELMED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 6
Use of Incorrect Control Settings 5
Device maintenance issue 2
Electrical issue 2
No Known Device Problem 2
Invalid sensing 1
Bent 1
Detachment of device component 1
Installation-related problem 1
Misassembled by Users 1
Component falling 1
Failure to conduct 1
Mechanical issue 1
Total Device Problems 25

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

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems (Schweiz) Ag II Sep-10-2013
2 Leica Microsystems, Inc. II Apr-15-2016
3 Leica Microsystems, Inc. II Jul-20-2012
4 Leica Microsystems, Inc. II Mar-21-2012
5 Leica Microsystems, Inc. II May-20-2010

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