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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
MENDAERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PARKER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 116 116
2021 146 154
2022 87 88
2023 138 138
2024 988 988
2025 378 378

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 963 963
Break 132 132
Leak/Splash 75 75
Adverse Event Without Identified Device or Use Problem 66 68
Material Deformation 54 54
Material Twisted/Bent 53 53
Fluid/Blood Leak 48 48
Detachment of Device or Device Component 39 39
Deformation Due to Compressive Stress 37 37
No Display/Image 34 34
Defective Component 31 31
Material Split, Cut or Torn 29 30
Failure to Clean Adequately 27 27
Stretched 25 25
Entrapment of Device 23 23
Device Contamination with Body Fluid 21 21
Material Integrity Problem 20 20
Material Puncture/Hole 17 17
Mechanical Problem 16 16
Mechanical Jam 15 15
Contamination /Decontamination Problem 15 17
No Apparent Adverse Event 14 14
Data Problem 14 14
Defective Device 13 13
Material Separation 13 13
Output Problem 11 11
Device Reprocessing Problem 11 11
Contamination 11 11
Scratched Material 11 11
Improper or Incorrect Procedure or Method 10 10
Crack 9 9
Device Contamination with Chemical or Other Material 9 9
Nonstandard Device 7 9
Failure to Advance 7 7
Display or Visual Feedback Problem 7 7
Positioning Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
Application Program Freezes, Becomes Nonfunctional 6 6
Patient-Device Incompatibility 6 6
Patient Device Interaction Problem 6 6
Dent in Material 5 5
Image Display Error/Artifact 5 5
Gas/Air Leak 4 4
Physical Resistance/Sticking 4 4
Material Perforation 4 4
Overheating of Device 4 4
Unable to Obtain Readings 4 4
Microbial Contamination of Device 4 4
Device Contaminated at the User Facility 3 3
Material Discolored 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1591 1592
No Consequences Or Impact To Patient 76 76
Insufficient Information 30 34
No Known Impact Or Consequence To Patient 29 29
Pneumothorax 20 20
Hemorrhage/Bleeding 17 17
Foreign Body In Patient 16 16
No Patient Involvement 12 12
Bacterial Infection 11 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Perforation of Vessels 5 5
Unspecified Infection 5 5
Burn, Thermal 5 5
Pneumonia 4 4
Rash 4 4
Fever 4 4
Perforation of Esophagus 3 3
Vascular Dissection 3 3
Pain 3 3
Chest Pain 3 3
Itching Sensation 3 3
Laceration(s) of Esophagus 3 3
Pancreatitis 3 3
Sepsis 3 3
Air Embolism 2 2
Fluid Discharge 2 2
Patient Problem/Medical Problem 2 2
Laceration(s) 2 2
Hypoxia 2 2
Urinary Retention 2 2
Ectopic Pregnancy 2 2
Electric Shock 2 2
Thrombosis/Thrombus 2 2
Burning Sensation 2 2
Gastroesophageal Burn 2 2
Vaginal Mucosa Damage 2 2
Cardiac Arrest 2 2
Skin Burning Sensation 2 2
Fibrosis 2 2
Device Embedded In Tissue or Plaque 2 2
Obstruction/Occlusion 2 2
Respiratory Failure 2 2
Hemoptysis 2 2
Urinary Tract Infection 2 2
Necrosis 2 2
Embolus 1 1
Headache 1 1
Deformity/ Disfigurement 1 1
Unspecified Respiratory Problem 1 1
Unspecified Heart Problem 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 Civco Medical Instruments Co. Inc. II May-30-2025
8 DJO, LLC I Oct-05-2021
9 Exact Medical Manufacturing, Inc. II Jun-21-2021
10 GE Medical Systems, LLC II Dec-22-2022
11 Hitachi Medical Systems America Inc II Feb-20-2020
12 Huntleigh Healthcare Ltd. II Apr-20-2022
13 ImaCor Inc. II Oct-03-2025
14 ImaCor Inc. II Oct-25-2024
15 Lumenis, Inc. I Nov-04-2021
16 Mac Medical Supply Co Inc I Sep-17-2021
17 National Distribution & Contracting Inc I Oct-13-2021
18 North Coast Medical Inc I Sep-29-2021
19 Olympus Corporation of the Americas II May-05-2022
20 Olympus Corporation of the Americas II Nov-27-2020
21 Philips Ultrasound Inc II May-01-2020
22 Philips Ultrasound, Inc III Aug-22-2025
23 Philips Ultrasound, Inc II Jul-02-2025
24 Philips Ultrasound, Inc. II Sep-06-2023
25 Red Medical Supplies I Oct-14-2021
26 Scrip Inc I Nov-17-2021
27 Verathon, Inc. II Dec-03-2020
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