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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
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CIVCO MEDICAL INSTRUMENTS CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
EXACT MEDICAL MANUFACTURING
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 1
HONY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDXPRESS.PRO
  SUBSTANTIALLY EQUIVALENT 1
PARKER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 116 116
2021 146 146
2022 87 87
2023 145 145
2024 1000 1000
2025 161 161

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 870 870
Break 114 114
Adverse Event Without Identified Device or Use Problem 75 75
Leak/Splash 66 66
Fluid/Blood Leak 47 47
Material Twisted/Bent 46 46
Material Deformation 43 43
Deformation Due to Compressive Stress 33 33
No Display/Image 32 32
Detachment of Device or Device Component 30 30
Defective Component 29 29
Material Split, Cut or Torn 28 28
Failure to Clean Adequately 24 24
Device Contamination with Body Fluid 21 21
Stretched 18 18
Mechanical Problem 16 16
Mechanical Jam 15 15
Entrapment of Device 15 15
Material Integrity Problem 15 15
Material Separation 13 13
Data Problem 12 12
Defective Device 12 12
Material Puncture/Hole 12 12
Contamination /Decontamination Problem 11 11
Contamination 11 11
Output Problem 11 11
Improper or Incorrect Procedure or Method 9 9
No Apparent Adverse Event 9 9
Device Contamination with Chemical or Other Material 9 9
Scratched Material 9 9
Device Reprocessing Problem 8 8
Crack 8 8
Therapeutic or Diagnostic Output Failure 7 7
Nonstandard Device 7 7
Display or Visual Feedback Problem 6 6
Patient-Device Incompatibility 6 6
Positioning Problem 6 6
Patient Device Interaction Problem 6 6
Dent in Material 4 4
Failure to Advance 4 4
Image Display Error/Artifact 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Material Perforation 4 4
Microbial Contamination of Device 4 4
Material Discolored 3 3
Positioning Failure 3 3
Unable to Obtain Readings 3 3
Sharp Edges 3 3
Device Handling Problem 3 3
Gel Leak 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1405 1405
No Consequences Or Impact To Patient 76 76
No Known Impact Or Consequence To Patient 29 29
Insufficient Information 28 28
Pneumothorax 20 20
Hemorrhage/Bleeding 17 17
Foreign Body In Patient 15 15
No Patient Involvement 12 12
Bacterial Infection 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Infection 5 5
Burn, Thermal 5 5
Perforation of Vessels 4 4
Pneumonia 4 4
Rash 4 4
Fever 4 4
Pancreatitis 3 3
Sepsis 3 3
Perforation of Esophagus 3 3
Pain 3 3
Chest Pain 3 3
Laceration(s) of Esophagus 3 3
Device Embedded In Tissue or Plaque 2 2
Urinary Tract Infection 2 2
Respiratory Failure 2 2
Fibrosis 2 2
Hypoxia 2 2
Fluid Discharge 2 2
Laceration(s) 2 2
Urinary Retention 2 2
Burning Sensation 2 2
Vaginal Mucosa Damage 2 2
Cardiac Arrest 2 2
Obstruction/Occlusion 2 2
Itching Sensation 2 2
Air Embolism 2 2
Patient Problem/Medical Problem 2 2
Ectopic Pregnancy 2 2
Electric Shock 2 2
Gastroesophageal Burn 2 2
Hemoptysis 2 2
Vascular Dissection 2 2
Necrosis 2 2
Decreased Appetite 1 1
Skin Burning Sensation 1 1
Fistula 1 1
Embolus 1 1
Low Oxygen Saturation 1 1
Abortion 1 1
Syncope/Fainting 1 1

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 DJO, LLC I Oct-05-2021
8 Exact Medical Manufacturing, Inc. II Jun-21-2021
9 GE Medical Systems, LLC II Dec-22-2022
10 Hitachi Medical Systems America Inc II Feb-20-2020
11 Huntleigh Healthcare Ltd. II Apr-20-2022
12 ImaCor Inc. II Oct-25-2024
13 Lumenis, Inc. I Nov-04-2021
14 Mac Medical Supply Co Inc I Sep-17-2021
15 National Distribution & Contracting Inc I Oct-13-2021
16 North Coast Medical Inc I Sep-29-2021
17 Olympus Corporation of the Americas II May-05-2022
18 Olympus Corporation of the Americas II Nov-27-2020
19 Philips Ultrasound Inc II May-01-2020
20 Philips Ultrasound, Inc. II Sep-06-2023
21 Red Medical Supplies I Oct-14-2021
22 Scrip Inc I Nov-17-2021
23 Verathon, Inc. II Dec-03-2020
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