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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device software, transmission and storage, patient data
Definition Non-alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored.
Product CodeNSX
Device Class Not Classified

Device Problems
Computer software issue 1
Incorrect or inadequate result 1
Device operates differently than expected 1
Total Device Problems 3

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 1 1 4 4 2 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cisco Systems Inc II Aug-24-2012
2 Philips Healthcare Inc. II May-10-2011
3 Picis Inc. II Jul-29-2013
4 Picis Inc. II Oct-31-2011
5 Picis Inc. II Sep-23-2011
6 Picis Inc. II Sep-07-2011
7 Picis Inc. II Apr-06-2010
8 Picis Inc. II Nov-18-2009
9 Roche Molecular Systems, Inc. II Dec-07-2012
10 Siemens Healthcare Diagnostics, Inc. II Dec-03-2013
11 Siemens Healthcare Diagnostics, Inc. II Aug-09-2012
12 Siemens Healthcare Diagnostics, Inc. II Aug-09-2012

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