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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
Product CodeITX
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B-K MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
BLACKTOE MEDICAL III, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHISON MEDICAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIVCO MEDICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
CIVCO MEDICAL INSTRUMENTS CO., INC.
  SUBSTANTIALLY EQUIVALENT 7
CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CORBIN CLINICAL RESOURCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXACT MEDICAL MANUFACTURING
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEM ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 1
GE VINGMED ULTRASOUND AS
  SUBSTANTIALLY EQUIVALENT 2
GEOTEK MEDIKAL LTD STI
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 1
HIGHLAND INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
HITACHI ALOKA MEDICAL AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI ALOKA MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HOUSTON MEDICAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 1
HUMANSCAN COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KOELIS
  SUBSTANTIALLY EQUIVALENT 3
MCUBE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
MEDXPRESS.PRO
  SUBSTANTIALLY EQUIVALENT 1
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARKER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFERSONIC MEDIZINPRODUKTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI
  SUBSTANTIALLY EQUIVALENT 1
SHEATHING TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
SONOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 1
STROKE2PREVENT B.V.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT DOPPLER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 1
TERATECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE NEWMAN GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
  SUBSTANTIALLY EQUIVALENT 1
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
  SUBSTANTIALLY EQUIVALENT 1
ULTRASONIX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 43 43
2015 182 182
2016 285 285
2017 412 412
2018 130 130
2019 119 119
2020 116 116
2021 146 146
2022 87 87
2023 145 145
2024 677 677

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 662 662
Device Displays Incorrect Message 279 279
Adverse Event Without Identified Device or Use Problem 118 118
Break 115 115
Device Operates Differently Than Expected 107 107
Fluid/Blood Leak 70 70
Leak/Splash 61 61
No Display/Image 54 54
Detachment of Device or Device Component 38 38
Mechanical Problem 37 37
Defective Component 36 36
Detachment Of Device Component 30 30
Signal Artifact/Noise 29 29
Material Deformation 29 29
Use of Device Problem 28 28
Material Twisted/Bent 27 27
Output Problem 25 25
Entrapment of Device 25 25
Mechanical Jam 24 24
Insufficient Information 22 22
Mechanics Altered 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Electrical /Electronic Property Problem 21 21
Failure to Clean Adequately 20 20
Material Separation 20 20
Deformation Due to Compressive Stress 20 20
Positioning Problem 20 20
Temperature Problem 19 19
Device Contamination with Body Fluid 18 18
Material Split, Cut or Torn 18 18
Crack 17 17
Image Display Error/Artifact 17 17
Overheating of Device 17 17
Computer Software Problem 17 17
Material Puncture/Hole 16 16
Display or Visual Feedback Problem 16 16
Data Problem 15 15
Device Contamination with Chemical or Other Material 15 15
Device Operational Issue 14 14
Defective Device 14 14
Computer Operating System Problem 14 14
Hole In Material 13 13
Device Inoperable 13 13
Contamination /Decontamination Problem 13 13
Split 12 12
Contamination 12 12
Therapeutic or Diagnostic Output Failure 12 12
Improper or Incorrect Procedure or Method 11 11
Material Integrity Problem 11 11
False Negative Result 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 955 955
No Consequences Or Impact To Patient 507 507
No Known Impact Or Consequence To Patient 450 450
No Patient Involvement 91 91
No Information 71 71
Insufficient Information 46 46
No Code Available 33 33
Pneumothorax 22 22
Hemorrhage/Bleeding 22 22
Foreign Body In Patient 20 20
Bacterial Infection 18 18
Perforation of Esophagus 13 13
Injury 11 11
Unspecified Infection 9 9
Stenosis 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Death 8 8
Low Blood Pressure/ Hypotension 8 8
Perforation 7 7
Burn(s) 6 6
Pain 6 6
Device Embedded In Tissue or Plaque 6 6
Pneumonia 5 5
Laceration(s) of Esophagus 5 5
Burn, Thermal 5 5
Fever 5 5
Perforation of Vessels 4 4
Chest Pain 4 4
Rash 4 4
Electric Shock 4 4
Patient Problem/Medical Problem 4 4
Sepsis 3 3
Pancreatitis 3 3
Pericardial Effusion 3 3
Burning Sensation 3 3
Cardiac Arrest 3 4
Tissue Damage 2 2
Hypoxia 2 2
Shock 2 2
Dysphagia/ Odynophagia 2 2
Fluid Discharge 2 2
Dyspnea 2 2
Laceration(s) 2 2
Fibrosis 2 2
Urinary Retention 2 2
Respiratory Failure 2 2
Needle Stick/Puncture 2 2
Cardiac Perforation 2 2
Chills 2 2
Urinary Tract Infection 2 2

Recalls
Manufacturer Recall Class Date Posted
1 AMTEC SALES Inc I Sep-22-2021
2 Accelerated Care Plus Corporation I Sep-25-2021
3 Advance Medical Designs, Inc. II Sep-09-2023
4 Aesthetics Systems Usa Inc I Oct-06-2021
5 Aizu Olympus Co., Ltd. II Nov-17-2023
6 Athena Medical Products Inc I Sep-09-2021
7 Boston Scientific Corporation II Jan-30-2014
8 Boston Scientific Corporation II Jan-28-2009
9 CIVCO Medical Instruments Co., Inc. II Dec-07-2018
10 Civco Medical Instruments Co. Inc. II Aug-29-2018
11 Civco Medical Instruments Co. Inc. II Aug-22-2018
12 Civco Medical Instruments Co. Inc. II Nov-17-2015
13 Civco Medical Instruments Inc II Apr-08-2015
14 Civco Medical Instruments Inc II Mar-08-2011
15 Civco Medical Instruments Inc II Aug-20-2010
16 DJO, LLC I Oct-05-2021
17 Exact Medical Manufacturing, Inc. II Jun-21-2021
18 GE Medical Systems, LLC II Dec-22-2022
19 Hitachi Medical Systems America Inc II Feb-20-2020
20 Hitachi Medical Systems America Inc II Mar-01-2018
21 Hitachi Medical Systems America Inc II Sep-09-2009
22 Huntleigh Healthcare Ltd. II Apr-20-2022
23 Lumenis, Inc. I Nov-04-2021
24 Mac Medical Supply Co Inc I Sep-17-2021
25 National Distribution & Contracting Inc I Oct-13-2021
26 North Coast Medical Inc I Sep-29-2021
27 Olympus Corporation of the Americas II May-05-2022
28 Olympus Corporation of the Americas II Nov-27-2020
29 Pentax Medical Company II Jun-28-2016
30 Pentax Medical Company II May-03-2012
31 Philips Ultrasound Inc II May-01-2020
32 Philips Ultrasound, Inc. II Sep-06-2023
33 Red Medical Supplies I Oct-14-2021
34 Scrip Inc I Nov-17-2021
35 Siemens Medical Solutions USA, Inc. II Sep-03-2014
36 Siemens Medical Solutions USA, Inc. II Apr-12-2011
37 Siemens Medical Solutions USA, Inc. II Feb-22-2011
38 Siemens Medical Solutions USA, Inc. II Feb-01-2011
39 Siemens Medical Solutions USA, Inc. II Jan-12-2011
40 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
41 Toshiba American Medical Systems Inc II Apr-12-2013
42 Toshiba American Medical Systems Inc II Jul-13-2010
43 Verathon, Inc. II Dec-03-2020
44 Verathon, Inc. III Oct-26-2010
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