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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 21
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 73
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 8
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 10
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 10
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 27
SIEMENS
  SUBSTANTIALLY EQUIVALENT 51
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 16
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 37
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical issue 30
Data Issue 20
No Known Device Problem 10
Split 7
Device operates differently than expected 6
Mechanical issue 4
Computer software issue 3
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 code available 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 95

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

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