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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 116 117
2021 146 154
2022 87 88
2023 138 138
2024 988 989
2025 529 529

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 1029 1030
Break 143 143
Leak/Splash 82 82
Adverse Event Without Identified Device or Use Problem 73 75
Material Twisted/Bent 63 64
Material Deformation 62 62
Fluid/Blood Leak 48 48
No Display/Image 44 44
Detachment of Device or Device Component 41 42
Deformation Due to Compressive Stress 39 39
Defective Component 33 33
Material Split, Cut or Torn 30 31
Failure to Clean Adequately 30 30
Stretched 27 27
Entrapment of Device 27 27
No Apparent Adverse Event 23 23
Device Contamination with Body Fluid 22 22
Material Integrity Problem 22 23
Material Puncture/Hole 20 20
Mechanical Problem 17 17
Contamination /Decontamination Problem 17 19
Mechanical Jam 15 15
Data Problem 15 15
Defective Device 14 14
Material Separation 13 13
Contamination 12 12
Device Reprocessing Problem 12 12
Scratched Material 11 11
Output Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Failure to Advance 10 10
Therapeutic or Diagnostic Output Failure 9 9
Crack 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
Device Contamination with Chemical or Other Material 9 9
Positioning Problem 7 7
Nonstandard Device 7 9
Display or Visual Feedback Problem 7 7
Patient-Device Incompatibility 6 6
Image Display Error/Artifact 6 6
Patient Device Interaction Problem 6 6
Unexpected Shutdown 6 6
Failure to Conduct 5 5
Physical Resistance/Sticking 5 5
Microbial Contamination of Device 5 5
Degraded 5 5
Dent in Material 5 5
Gas/Air Leak 5 5
Insufficient Information 4 4
Overheating of Device 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1732 1735
No Consequences Or Impact To Patient 76 76
Insufficient Information 33 38
No Known Impact Or Consequence To Patient 29 29
Pneumothorax 20 20
Foreign Body In Patient 17 17
Hemorrhage/Bleeding 17 17
No Patient Involvement 12 12
Bacterial Infection 11 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Vascular Dissection 6 6
Unspecified Infection 5 5
Perforation of Vessels 5 5
Burn, Thermal 5 5
Pneumonia 4 4
Pain 4 4
Fever 4 4
Rash 4 4
Pancreatitis 3 3
Ectopic Pregnancy 3 3
Chest Pain 3 3
Sepsis 3 3
Perforation of Esophagus 3 3
Itching Sensation 3 3
Laceration(s) of Esophagus 3 3
Fluid Discharge 2 2
Laceration(s) 2 2
Urinary Retention 2 2
Thrombosis/Thrombus 2 2
Hypoxia 2 2
Burning Sensation 2 2
Cardiac Arrest 2 2
Vaginal Mucosa Damage 2 2
Obstruction/Occlusion 2 2
Fibrosis 2 2
Hemoptysis 2 2
Respiratory Failure 2 2
Necrosis 2 2
Gastroesophageal Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Urinary Tract Infection 2 2
Electric Shock 2 2
Skin Burning Sensation 2 2
Air Embolism 2 2
Patient Problem/Medical Problem 2 2
Headache 1 1
Sore Throat 1 1
Deformity/ Disfigurement 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory 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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