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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
Component falling 3
Fluid leak 3
No Information 2
Sticking 2
Use of Device Issue 1
Improper or incorrect procedure or method 1
Residue after decontamination 1
Device Issue 1
Obstruction within device 1
Device operates differently than expected 1
No Known Device Problem 1
Unintended movement 1
Misassembled by Users 1
Unintended system motion 1
Entrapment of device or device component 1
Fire 1
Collapse 1
Detachment of device component 1
Total Device Problems 24

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Getinge USA Inc II Jul-26-2012
2 Steris Corporation II Aug-01-2012
3 Steris Corporation II Sep-01-2011

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