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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
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CIVCO MEDICAL INSTRUMENTS CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
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

MDR Year MDR Reports MDR Events
2019 119 119
2020 116 116
2021 146 146
2022 87 87
2023 145 145
2024 576 576

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 521 521
Adverse Event Without Identified Device or Use Problem 96 96
Break 83 83
Fluid/Blood Leak 48 48
Leak/Splash 47 47
No Display/Image 34 34
Defective Component 28 28
Material Twisted/Bent 24 24
Detachment of Device or Device Component 22 22
Failure to Clean Adequately 20 20
Mechanical Problem 18 18
Material Deformation 18 18
Device Contamination with Body Fluid 17 17
Deformation Due to Compressive Stress 15 15
Material Split, Cut or Torn 15 15
Entrapment of Device 14 14
Mechanical Jam 13 13
Therapeutic or Diagnostic Output Failure 12 12
Material Separation 12 12
Material Puncture/Hole 11 11
Defective Device 11 11
Data Problem 11 11
Output Problem 10 10
Material Integrity Problem 10 10
Device Contamination with Chemical or Other Material 10 10
Contamination /Decontamination Problem 10 10
Contamination 10 10
Display or Visual Feedback Problem 9 9
Improper or Incorrect Procedure or Method 9 9
Stretched 8 8
Image Display Error/Artifact 8 8
No Apparent Adverse Event 8 8
Nonstandard Device 7 7
Device Reprocessing Problem 7 7
Patient-Device Incompatibility 6 6
Positioning Problem 6 6
Temperature Problem 5 5
Patient Device Interaction Problem 5 5
Crack 5 5
Microbial Contamination of Device 4 4
Failure to Advance 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Physical Resistance/Sticking 3 3
Insufficient Information 3 3
Device Displays Incorrect Message 3 3
Material Perforation 3 3
Unable to Obtain Readings 3 3
Signal Artifact/Noise 3 3
Electrical /Electronic Property Problem 3 3
Loss of Power 3 3
Difficult to Insert 3 3
Gel Leak 3 3
Computer Software Problem 2 2
Failure to Power Up 2 2
Off-Label Use 2 2
Overheating of Device 2 2
Unsealed Device Packaging 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Fire 2 2
Positioning Failure 2 2
Material Discolored 2 2
Unexpected Therapeutic Results 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Markings/Labelling Problem 2 2
Appropriate Term/Code Not Available 2 2
Improper Flow or Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Dislodged or Dislocated 2 2
Device Handling Problem 2 2
Activation Failure 2 2
Activation Problem 2 2
Unexpected Color 1 1
Device Contaminated at the User Facility 1 1
Noise, Audible 1 1
Unexpected Shutdown 1 1
Intermittent Energy Output 1 1
Electrical Shorting 1 1
Environmental Particulates 1 1
Mechanics Altered 1 1
Scratched Material 1 1
Operating System Becomes Nonfunctional 1 1
Device Damaged by Another Device 1 1
Loss of Data 1 1
Activation, Positioning or Separation Problem 1 1
Battery Problem 1 1
Charging Problem 1 1
Sparking 1 1
Malposition of Device 1 1
Dent in Material 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Failure to Sense 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 832 832
No Consequences Or Impact To Patient 109 109
No Known Impact Or Consequence To Patient 82 82
Insufficient Information 27 27
Pneumothorax 22 22
No Patient Involvement 19 19
Hemorrhage/Bleeding 17 17
Foreign Body In Patient 14 14
Bacterial Infection 11 11
Stenosis 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Injury 6 6
Perforation of Esophagus 6 6
Unspecified Infection 6 6
Burn, Thermal 5 5
Rash 4 4
Perforation of Vessels 4 4
Pneumonia 4 4
Fever 4 4
Chest Pain 4 4
Pain 3 3
Perforation 3 3
Sepsis 3 3
Patient Problem/Medical Problem 3 3
No Code Available 3 3
Laceration(s) of Esophagus 3 3
Pancreatitis 3 3
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Gastroesophageal Burn 2 2
Fluid Discharge 2 2
Respiratory Failure 2 2
Burning Sensation 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Vaginal Mucosa Damage 2 2
Obstruction/Occlusion 2 2
Hemoptysis 2 2
Inflammation 2 2
Itching Sensation 2 2
Hypoxia 2 2
Necrosis 2 2
Air Embolism 2 2
Cardiac Arrest 2 2
Dyspnea 2 2
Embolus 1 1
Fistula 1 1
Headache 1 1
Hematoma 1 1
Aspiration/Inhalation 1 1
Abortion 1 1
Abrasion 1 1
Congenital Defect/Deformity 1 1
Conjunctivitis 1 1
Purulent Discharge 1 1
Dysphagia/ Odynophagia 1 1
Occlusion 1 1
Laceration(s) 1 1
Seroma 1 1
Skin Irritation 1 1
Tissue Damage 1 1
Ulceration 1 1
Low Oxygen Saturation 1 1
Respiratory Tract Infection 1 1
Sore Throat 1 1
Discomfort 1 1
Scar Tissue 1 1
Chills 1 1
Blurred Vision 1 1
Vomiting 1 1
Skin Tears 1 1
Electric Shock 1 1
Bronchospasm 1 1
Syncope/Fainting 1 1
Taste Disorder 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Bronchial Hemorrhage 1 1
Cough 1 1
Pleural Empyema 1 1
Unspecified Respiratory Problem 1 1
Hematemesis 1 1
No Information 1 1
Vascular Dissection 1 1
Skin Burning Sensation 1 1
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 1 1
Nodule 1 1
Decreased Appetite 1 1
Swelling/ Edema 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 Lumenis, Inc. I Nov-04-2021
13 Mac Medical Supply Co Inc I Sep-17-2021
14 National Distribution & Contracting Inc I Oct-13-2021
15 North Coast Medical Inc I Sep-29-2021
16 Olympus Corporation of the Americas II May-05-2022
17 Olympus Corporation of the Americas II Nov-27-2020
18 Philips Ultrasound Inc II May-01-2020
19 Philips Ultrasound, Inc. II Sep-06-2023
20 Red Medical Supplies I Oct-14-2021
21 Scrip Inc I Nov-17-2021
22 Verathon, Inc. II Dec-03-2020
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