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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 4
CIVCO
  SUBSTANTIALLY EQUIVALENT 12
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
Device displays error message 100
Use of Device Issue 23
Incorrect or inadequate result 20
Electrical issue 20
Computer software issue 17
Device operates differently than expected 16
Split 12
Poor quality image 12
Data Issue 12
Break 11
False negative result 10
Low readings 10
Invalid sensing 9
Output issue 8
Detachment of device or device component 7
Disinfection or Sterilization Issue at User Location 7
Fracture 7
Entrapment of device or device component 6
Retraction problem 6
No Information 6
Temperature issue 5
Improper device output 5
No Known Device Problem 5
Detachment of device component 5
Overheating of device or device component 5
Mechanical issue 5
Difficult to remove 4
No display or display failure 4
Material separation 4
Bacterial contamination of device 4
Incorrect or inadequate test results 4
No code available 4
Low test results 3
Connection issue 3
Crack 3
Material puncture 3
Performance 2
Difficult to position 2
Normal 2
Fluid leak 2
Hole in material 2
Leak 2
Issue with displayed error message 2
Foreign material present in device 2
Physical resistance 2
Defective item 2
Smoking 2
Tip breakage 2
Failure to sense 2
Improper or incorrect procedure or method 1
Material perforation 1
Device inoperable 1
High Readings 1
Failure to align 1
Device Issue 1
Failure to calibrate 1
Computer system security issue 1
Device or device component damaged by another device 1
Device sensing issue 1
Electrical overstress 1
Electronic property issue 1
Positioning Issue 1
Material Protrusion 1
Incorrect measurement 1
Image resolution poor 1
Difficult to insert 1
Difficult to flush 1
Material fragmentation 1
Grounding malfunction 1
Product quality issue 1
Device remains activated 1
Difficult to deploy 1
Design/structure problem 1
Failure to disinfect 1
Erratic display 1
Coiled 1
Component(s), broken 1
Artifact 1
Loss of or failure to bond 1
Contamination during use 1
Fire 1
Torn material 1
Not Applicable 1
Device handling issue 1
Total Device Problems 446

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 2 2 6 1 1 2 2 1 0
Class III 0 1 0 1 0 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 Jun-28-2016
10 Pentax Medical Company II May-03-2012
11 Siemens Medical Solutions USA, Inc. II Sep-03-2014
12 Siemens Medical Solutions USA, Inc. II Apr-12-2011
13 Siemens Medical Solutions USA, Inc. II Feb-22-2011
14 Siemens Medical Solutions USA, Inc. II Feb-01-2011
15 Siemens Medical Solutions USA, Inc. II Jan-12-2011
16 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
17 Toshiba American Med Sys Inc II May-05-2007
18 Toshiba American Medical Systems Inc II Apr-12-2013
19 Toshiba American Medical Systems Inc II Jul-13-2010
20 Verathon, Inc. III Oct-26-2010

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