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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device disinfector, medical devices
Regulation Description Medical washer-disinfector.
Product CodeMEC
Regulation Number 880.6992
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fire 10
Fluid leak 7
Smoking 5
Component falling 4
Leak 3
Use of Device Issue 3
Improper or incorrect procedure or method 3
Residue after decontamination 3
No Known Device Problem 3
No Information 2
Fumes or vapors 2
Device operates differently than expected 2
Sticking 2
Component missing 1
Device Issue 1
Obstruction within device 1
Unintended system motion 1
Overheating of device or device component 1
Entrapment of device or device component 1
Collapse 1
Detachment of device component 1
Unintended movement 1
Misassembled by Users 1
Total Device Problems 59

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

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Disinfection II Oct-17-2013
2 Getinge Disinfection Ab III Aug-25-2015
3 Getinge Disinfection Ab II Dec-23-2014
4 Getinge USA Inc II Jul-26-2012
5 Steris Corporation III Jul-10-2014
6 Steris Corporation II Aug-01-2012
7 Steris Corporation II Sep-01-2011

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