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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cart, emergency, cardiopulmonary (excluding equipment)
Regulation Description Cardiopulmonary emergency cart.
Product CodeBZN
Regulation Number 868.6175
Device Class 1


Premarket Reviews
ManufacturerDecision
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Spark 2
Device operates differently than expected 2
No Information 1
Connection issue 1
Crack 1
Electrical issue 1
Device inoperable 1
Total Device Problems 11

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Endoscopy II Sep-24-2013

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