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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device medical computers and software
Product CodeLNX
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer software issue 7
Programming issue 6
Medication Error 3
Data Issue 2
Patient Data Issue 2
Device alarm system issue 1
Alarm not visible 1
Failure to back-up 1
Device Issue 1
Data back-up problem 1
Installation-related problem 1
Total Device Problems 26

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 10 5 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxa Corporation I May-25-2012
2 Baxter Corporation Englewood II Dec-18-2013
3 SCC Soft Computer II Dec-02-2011
4 SCC Soft Computer II Dec-02-2011
5 SCC Soft Computer II Nov-23-2011
6 SCC Soft Computer II Nov-23-2011
7 SCC Soft Computer II Jun-30-2011
8 SCC Soft Computer II Nov-15-2010
9 SCC Soft Computer II Oct-20-2010
10 SCC Soft Computer II Oct-20-2010
11 SCC Soft Computer II Oct-20-2010
12 SCC Soft Computer II Oct-19-2010
13 SCC Soft Computer II Oct-19-2010
14 SCC Soft Computer II Oct-19-2010
15 SCC Soft Computer II Oct-18-2010
16 SCC Soft Computer II Oct-15-2010
17 SCC Soft Computer II Oct-15-2010
18 Sorin Group Italia S.r.l. II Jan-22-2014

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