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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, imaging, pulsed doppler, ultrasonic
Regulation Description Ultrasonic pulsed doppler imaging system.
Product CodeIYN
Regulation Number 892.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 17
ACUSON
  SUBSTANTIALLY EQUIVALENT 7
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ATL ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE
  SUBSTANTIALLY EQUIVALENT 20
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 72
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 8
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
LARSEN & TOUBRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDISON
  SUBSTANTIALLY EQUIVALENT 9
NICOLET BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 27
SIEMENS
  SUBSTANTIALLY EQUIVALENT 48
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 16
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 34
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical issue 30
Data Issue 20
No Known Device Problem 9
Split 7
Device operates differently than expected 6
Mechanical issue 4
Computer software issue 2
Incorrect measurement 2
Use of Device Issue 2
Defective component 1
Device displays error message 1
Computer operating system issue 1
Power source issue 1
No display or display failure 1
Artifact 1
Component falling 1
Device emits odor 1
Device stops intermittently 1
Image resolution poor 1
Total Device Problems 92

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 4 13 1 4 16 4 8 11 10 4
Class III 1 1 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 B & K Medical Systems, Inc. II Jun-10-2008
2 Bard Access Systems II Jul-11-2011
3 Boston Scientific Corporation II Apr-22-2014
4 Boston Scientific Corporation II Sep-17-2008
5 Cardinal Health, Inc II Apr-07-2009
6 GE Healthcare Clinical Systems II Jun-12-2008
7 GE Healthcare, LLC II Apr-23-2014
8 GE Healthcare, LLC II Aug-09-2013
9 GE Healthcare, LLC II Aug-01-2013
10 GE Healthcare, LLC II Jul-31-2013
11 GE Healthcare, LLC II Apr-11-2013
12 GE Healthcare, LLC II Feb-23-2012
13 GE Healthcare, LLC II Jan-21-2012
14 GE Healthcare, LLC II Jan-11-2012
15 Hitachi Medical Systems America Inc II Jun-08-2011
16 Philips Medical Systems II Dec-31-2008
17 Philips Medical Systems II Sep-16-2008
18 Philips Medical Systems II Jul-03-2007
19 Philips Medical Systems Nederlands II Apr-25-2011
20 Philips Medical Systems North America Inc. II Mar-20-2014
21 Philips Medical Systems North America Inc. II Nov-20-2013
22 Philips Ultrasound, Inc. II Apr-13-2016
23 Philips Ultrasound, Inc. II Jan-06-2016
24 Philips Ultrasound, Inc. II May-19-2015
25 Philips Ultrasound, Inc. II May-05-2015
26 Philips Ultrasound, Inc. II Dec-16-2014
27 Philips Ultrasound, Inc. II Feb-17-2007
28 Siemens Medical Solutions USA, Inc. II May-02-2016
29 Siemens Medical Solutions USA, Inc. II Apr-27-2016
30 Siemens Medical Solutions USA, Inc. II Oct-30-2015
31 Siemens Medical Solutions USA, Inc. II Sep-17-2015
32 Siemens Medical Solutions USA, Inc. II Aug-05-2015
33 Siemens Medical Solutions USA, Inc. II Jul-30-2015
34 Siemens Medical Solutions USA, Inc. II Jul-29-2015
35 Siemens Medical Solutions USA, Inc. II Jul-02-2015
36 Siemens Medical Solutions USA, Inc. II May-06-2015
37 Siemens Medical Solutions USA, Inc. II Feb-05-2015
38 Siemens Medical Solutions USA, Inc. II Jul-01-2014
39 Siemens Medical Solutions USA, Inc. II May-28-2014
40 Siemens Medical Solutions USA, Inc. II May-28-2014
41 Siemens Medical Solutions USA, Inc. II Apr-24-2014
42 Siemens Medical Solutions USA, Inc. II Apr-03-2014
43 Siemens Medical Solutions USA, Inc. II Jan-24-2014
44 Siemens Medical Solutions USA, Inc. II Jan-24-2014
45 Siemens Medical Solutions USA, Inc. II Oct-23-2013
46 Siemens Medical Solutions USA, Inc. II Apr-10-2013
47 Siemens Medical Solutions USA, Inc. II May-16-2012
48 Siemens Medical Solutions USA, Inc. II May-06-2011
49 Siemens Medical Solutions USA, Inc. II Apr-29-2011
50 Siemens Medical Solutions USA, Inc. II Apr-25-2011
51 Siemens Medical Solutions USA, Inc. II Apr-22-2011
52 Siemens Medical Solutions USA, Inc. II Apr-08-2011
53 Siemens Medical Solutions USA, Inc. II Mar-30-2011
54 Siemens Medical Solutions USA, Inc. II Mar-28-2011
55 Siemens Medical Solutions USA, Inc. II Feb-01-2011
56 Siemens Medical Solutions USA, Inc. II Dec-28-2010
57 Siemens Medical Solutions USA, Inc. II Oct-10-2008
58 Siemens Medical Solutions USA, Inc. II Oct-08-2008
59 Siemens Medical Solutions USA, Inc. II Sep-29-2008
60 Siemens Medical Solutions USA, Inc. II Sep-19-2008
61 Siemens Medical Solutions USA, Inc. III Sep-02-2008
62 Siemens Medical Solutions USA, Inc. II Apr-24-2008
63 Siemens Medical Solutions USA, Inc. II Feb-15-2008
64 Siemens Medical Solutions USA, Inc. II Jan-09-2008
65 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
66 Sonosite, Inc. II Oct-18-2011
67 Sonosite, Inc. III Nov-26-2010
68 Sonosite, Inc. II Oct-01-2010
69 Sonosite, Inc. II Aug-02-2010
70 Sonosite, Inc. II Mar-29-2007
71 Toshiba American Med Sys Inc II Jan-09-2008
72 Toshiba American Med Sys Inc III Nov-17-2007
73 Toshiba American Med Sys Inc II Jun-27-2007
74 Toshiba American Medical Systems Inc II Oct-30-2013
75 Toshiba American Medical Systems Inc II Jul-29-2011
76 Toshiba American Medical Systems Inc II May-19-2011
77 Toshiba American Medical Systems Inc II May-10-2011
78 Toshiba American Medical Systems Inc II Mar-19-2010

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