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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, ultrasonic, diagnostic
Regulation Description Diagnostic ultrasonic transducer.
Product CodeITX
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 8
ACUSON
  SUBSTANTIALLY EQUIVALENT 11
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATL ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CIVCO
  SUBSTANTIALLY EQUIVALENT 10
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJI
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 21
GYNESONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 7
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 2
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
KRETZTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 4
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISON
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 10
PENTAX
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 19
VASCULAR CONTROL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Use of Device Issue 22
Electrical issue 19
Computer software issue 17
Split 12
Data Issue 12
Device operates differently than expected 11
Poor quality image 11
False negative result 10
Incorrect or inadequate result 10
Invalid sensing 9
Low readings 8
Fracture 6
Break 6
Detachment of device or device component 6
No Information 5
Incorrect or inadequate test results 4
No code available 4
Retraction problem 4
No display or display failure 4
No Known Device Problem 3
Mechanical issue 3
Low test results 3
Foreign material present in device 2
Normal 2
Detachment of device component 2
Leak 2
Difficult to position 2
Fluid leak 2
Defective item 2
Entrapment of device or device component 2
Device displays error message 2
Failure to sense 2
Physical resistance 2
Performance 2
Tip breakage 2
Image resolution poor 1
Product quality issue 1
Electronic property issue 1
Improper device output 1
Issue with displayed error message 1
Computer system security issue 1
Difficult to remove 1
Fire 1
Difficult to deploy 1
Device remains activated 1
Difficult to flush 1
Material puncture 1
Artifact 1
Smoking 1
Failure to calibrate 1
Grounding malfunction 1
Difficult to insert 1
Failure to align 1
Electrical overstress 1
Output issue 1
Component(s), broken 1
Crack 1
Bacterial contamination of device 1
Hole in material 1
Material separation 1
Device Issue 1
Device handling issue 1
Design/structure problem 1
Total Device Problems 243

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 1 0 2 2 6 1 1 2 2 0
Class III 0 1 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jan-30-2014
2 Boston Scientific Corporation II Jan-28-2009
3 Civco Medical Instruments Co. Inc. II Nov-17-2015
4 Civco Medical Instruments Inc II Apr-08-2015
5 Civco Medical Instruments Inc II Mar-08-2011
6 Civco Medical Instruments Inc II Aug-20-2010
7 Civco Medical Instruments Inc III Mar-19-2008
8 Hitachi Medical Systems America Inc II Sep-09-2009
9 Pentax Medical Company II May-03-2012
10 Siemens Medical Solutions USA, Inc. II Sep-03-2014
11 Siemens Medical Solutions USA, Inc. II Apr-12-2011
12 Siemens Medical Solutions USA, Inc. II Feb-22-2011
13 Siemens Medical Solutions USA, Inc. II Feb-01-2011
14 Siemens Medical Solutions USA, Inc. II Jan-12-2011
15 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
16 Toshiba American Med Sys Inc II May-05-2007
17 Toshiba American Medical Systems Inc II Apr-12-2013
18 Toshiba American Medical Systems Inc II Jul-13-2010
19 Verathon, Inc. III Oct-26-2010

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