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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 1
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 401 401

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 417 417
Adverse Event Without Identified Device or Use Problem 95 95
Break 74 74
Fluid/Blood Leak 46 46
Leak/Splash 37 37
No Display/Image 31 31
Defective Component 28 28
Detachment of Device or Device Component 22 22
Failure to Clean Adequately 19 19
Material Twisted/Bent 18 18
Mechanical Problem 17 17
Entrapment of Device 14 14
Mechanical Jam 13 13
Therapeutic or Diagnostic Output Failure 12 12
Material Separation 12 12
Device Contamination with Body Fluid 12 12
Defective Device 11 11
Material Puncture/Hole 10 10
Output Problem 10 10
Device Contamination with Chemical or Other Material 10 10
Data Problem 10 10
Material Split, Cut or Torn 9 9
Improper or Incorrect Procedure or Method 9 9
Contamination /Decontamination Problem 8 8
Display or Visual Feedback Problem 8 8
Contamination 8 8
Image Display Error/Artifact 8 8
Material Integrity Problem 8 8
No Apparent Adverse Event 7 7
Nonstandard Device 7 7
Device Reprocessing Problem 7 7
Patient-Device Incompatibility 6 6
Positioning Problem 6 6
Material Deformation 6 6
Temperature Problem 5 5
Patient Device Interaction Problem 5 5
Application Program Freezes, Becomes Nonfunctional 4 4
Microbial Contamination of Device 4 4
Stretched 4 4
Crack 4 4
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
Material Perforation 3 3
Unable to Obtain Readings 3 3
Failure to Advance 3 3
Device Displays Incorrect Message 3 3
Physical Resistance/Sticking 3 3
Insufficient Information 3 3
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
Deformation Due to Compressive Stress 2 2
Device Markings/Labelling Problem 2 2
Unexpected Therapeutic Results 2 2
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
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Premature Discharge of Battery 1 1
Loss of or Failure to Bond 1 1
Thermal Decomposition of Device 1 1
Difficult or Delayed Positioning 1 1
Collapse 1 1
Delivered as Unsterile Product 1 1
Energy Output Problem 1 1
No Device Output 1 1
Material Frayed 1 1
Incorrect Measurement 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 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
Product Quality Problem 1 1
Smoking 1 1
Device Damaged by Another Device 1 1
Activation, Positioning or Separation Problem 1 1
Charging Problem 1 1
Battery Problem 1 1
Sparking 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 659 659
No Consequences Or Impact To Patient 109 109
No Known Impact Or Consequence To Patient 82 82
Insufficient Information 26 26
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
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
Fluid Discharge 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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