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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 echo, ultrasonic
Regulation Description Ultrasonic pulsed echo imaging system.
Product CodeIYO
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 8
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ACCUTOME ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACUSON
  SUBSTANTIALLY EQUIVALENT 10
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
ARDENT SOUND, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 7
BRYMILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CANON
  SUBSTANTIALLY EQUIVALENT 2
CIVCO
  SUBSTANTIALLY EQUIVALENT 7
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ELLEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 41
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 14
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 4
KILTEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
KRETZTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 1
LIFE-TECH INT'L., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISON
  SUBSTANTIALLY EQUIVALENT 10
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
OPKO
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  1
  SUBSTANTIALLY EQUIVALENT 6
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
REICHERT INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 11
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS
  SUBSTANTIALLY EQUIVALENT 29
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 3
SOUNMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STORZ
  SUBSTANTIALLY EQUIVALENT 1
TOMEY CORP.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 21
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 16

Device Problems
Retraction problem 163
Incorrect measurement 94
Data Issue 29
No code available 18
Power calculation error due to software problem 17
False reading from device non-compliance 7
Device operates differently than expected 6
No Known Device Problem 6
Erratic display 5
Incorrect or inadequate result 5
Failure to power-up 4
Inaccurate synchronization 4
Circuit Failure 4
Device displays error message 4
Calibration issue 4
Material separation 3
Device Issue 3
Operating system becomes non-functional 3
Split 3
Computer software issue 3
Electrical issue 3
Incorrect software programming calculations 3
Performance 2
Use of Device Issue 2
Shock, electrical 2
No display or display failure 2
No Information 2
Device damaged prior to use 2
Electrical shorting 2
Inadequate lighting 1
Maintenance does not comply to manufacturers recommendations 1
Material integrity issue 1
Measurement system incompatibility 1
Communication or transmission issue 1
Connection issue 1
Sharp/jagged/rough/etched/scratched 1
Tube(s), defective 1
Smoking 1
Malfunction 1
Cut in material 1
Incorrect or inadequate test results 1
Low readings 1
Output issue 1
Difficult to advance 1
Incorrect display 1
Break 1
Burn of device or device component 1
Contamination during use 1
Use of Incorrect Control Settings 1
Decoupling 1
Disconnection 1
Device emits odor 1
Overheating of device or device component 1
Fluid leak 1
Leak 1
Loose or intermittent connection 1
Improper or incorrect procedure or method 1
Electro-static discharge 1
Unknown (for use when the device problem is not known) 1
Tears, rips, holes in device, device material 1
Tip breakage 1
Transducer failure 1
Undercorrection 1
Device inoperable 1
Failure to sense 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Total Device Problems 443

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 2 4 3 5 7 4 4 2 4 1
Class III 2 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-16-2008
2 Boston Scientific Corporation II Sep-23-2008
3 Civco Medical Instruments Inc II Jul-06-2012
4 Ellex Inc. II Dec-28-2007
5 GE Healthcare II Sep-22-2008
6 GE Healthcare, LLC II Nov-21-2013
7 GE Medical Systems, LLC II Dec-16-2009
8 GE Medical Systems, LLC II Nov-09-2009
9 Ge Healthcare II Nov-07-2007
10 Parker Laboratories, Inc. II Oct-29-2014
11 Siemens Medical Solutions USA, Inc. II May-05-2015
12 Siemens Medical Solutions USA, Inc. II Feb-07-2015
13 Siemens Medical Solutions USA, Inc. II Mar-09-2013
14 Siemens Medical Solutions USA, Inc. II May-30-2012
15 Siemens Medical Solutions USA, Inc. II May-06-2011
16 Siemens Medical Solutions USA, Inc. II Apr-25-2011
17 Siemens Medical Solutions USA, Inc. II Apr-04-2011
18 Siemens Medical Solutions USA, Inc. II Feb-01-2011
19 Siemens Medical Solutions USA, Inc. II Sep-11-2008
20 Siemens Medical Solutions USA, Inc. III Sep-02-2008
21 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
22 Soma Access Systems LLC II Dec-16-2014
23 SonoSite, Inc. II Oct-18-2013
24 Sonogage Inc II Sep-16-2013
25 Sonosite, Inc. II Aug-09-2010
26 Toshiba American Med Sys Inc III Nov-17-2007
27 Toshiba American Medical Systems Inc II Aug-10-2011
28 Toshiba American Medical Systems Inc II Mar-03-2011
29 Toshiba American Medical Systems Inc II Jul-06-2010
30 Toshiba American Medical Systems Inc II Mar-11-2010
31 Verathon, Inc. II Mar-10-2016
32 Verathon, Inc. II Oct-04-2010
33 Verathon, Inc. II Sep-17-2009
34 Volcano Corp II Jul-08-2015
35 Volcano Corporation II Jul-20-2015
36 Volcano Corporation II Sep-10-2012
37 Volcano Corporation II Feb-07-2012
38 Volcano Corporation II Nov-01-2010
39 Volcano Corporation III Aug-23-2007

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