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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lithotriptor, extracorporeal shock-wave,urological
Regulation Description Extracorporeal shock wave lithotripter.
Product CodeLNS
Regulation Number 876.5990
Device Class 2


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 4
EDAP TECHNOMED
  SUBSTANTIALLY EQUIVALENT 1
HEALTHTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 6
MEDISPEC, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 42
Normal 11
Kinked 3
Device Issue 2
Failure to disconnect 1
Device displays error message 1
Failure to fire 1
Connection issue 1
Device operates differently than expected 1
Dislodged or dislocated 1
Unintended system motion 1
Inappropriate shock 1
Unintended movement 1
Total Device Problems 67

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

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Medical Solutions USA, Inc II Nov-12-2015

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