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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
BIOBOT SURGICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIVCO MEDICAL INSTRUMENTS CO., INC.
  SUBSTANTIALLY EQUIVALENT 4
CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  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
GEOTEK MEDIKAL LTD STI
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 1
HONY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KOELIS
  SUBSTANTIALLY EQUIVALENT 2
MEDXPRESS.PRO
  SUBSTANTIALLY EQUIVALENT 1
STROKE2PREVENT B.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 412 412
2018 130 130
2019 119 119
2020 116 116
2021 146 146
2022 87 87
2023 145 145
2024 283 283

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 374 374
Device Displays Incorrect Message 223 223
Adverse Event Without Identified Device or Use Problem 98 98
Break 81 81
Fluid/Blood Leak 64 64
No Display/Image 41 41
Leak/Splash 41 41
Defective Component 31 31
Detachment of Device or Device Component 30 30
Detachment Of Device Component 22 22
Signal Artifact/Noise 22 22
Entrapment of Device 20 20
Device Operates Differently Than Expected 20 20
Failure to Clean Adequately 18 18
Temperature Problem 17 17
Output Problem 17 17
Mechanical Problem 17 17
Image Display Error/Artifact 16 16
Material Separation 15 15
Device Contamination with Chemical or Other Material 15 15
Positioning Problem 14 14
Material Twisted/Bent 14 14
Mechanical Jam 14 14
Therapeutic or Diagnostic Output Failure 12 12
Device Contamination with Body Fluid 12 12
Material Puncture/Hole 12 12
Display or Visual Feedback Problem 12 12
Defective Device 11 11
Device Operational Issue 11 11
Contamination /Decontamination Problem 11 11
Data Problem 10 10
Crack 10 10
Loss of Power 10 10
Overheating of Device 10 10
Improper or Incorrect Procedure or Method 10 10
Contamination 9 9
No Apparent Adverse Event 8 8
Insufficient Information 8 8
Material Split, Cut or Torn 8 8
Noise, Audible 7 7
Microbial Contamination of Device 7 7
Device Reprocessing Problem 7 7
Difficult to Remove 7 7
Nonstandard Device 7 7
Device Inoperable 6 6
Patient-Device Incompatibility 6 6
Battery Problem 6 6
Material Integrity Problem 6 6
Patient Device Interaction Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Appropriate Term/Code Not Available 5 5
Material Deformation 5 5
Retraction Problem 5 5
Loss of or Failure to Bond 5 5
Stretched 4 4
Hole In Material 4 4
Failure to Power Up 4 4
Component Missing 4 4
Device Damaged by Another Device 4 4
Improper Device Output 4 4
Device Dislodged or Dislocated 3 3
Communication or Transmission Problem 3 3
Failure to Advance 3 3
Residue After Decontamination 3 3
Failure to Sense 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Handling Problem 3 3
Operating System Becomes Nonfunctional 3 3
Physical Resistance/Sticking 3 3
Unsealed Device Packaging 3 3
Difficult to Insert 3 3
Use of Device Problem 3 3
Material Perforation 3 3
Unable to Obtain Readings 3 3
Component Falling 3 3
Computer Software Problem 3 3
Electrical /Electronic Property Problem 3 3
Gel Leak 3 3
Fracture 3 3
Problem with Removal of Enzymatic Cleaner 2 2
Fire 2 2
Erratic or Intermittent Display 2 2
Positioning Failure 2 2
Material Discolored 2 2
Thermal Decomposition of Device 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
No Device Output 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Unexpected Therapeutic Results 2 2
Smoking 2 2
Device Stops Intermittently 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Melted 2 2
Off-Label Use 2 2
Torn Material 2 2
Activation Failure 2 2
Mechanics Altered 2 2
Failure to Disconnect 2 2
Difficult or Delayed Activation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 571 571
No Consequences Or Impact To Patient 337 337
No Known Impact Or Consequence To Patient 198 198
No Patient Involvement 73 73
No Information 47 47
Insufficient Information 45 45
No Code Available 26 26
Pneumothorax 22 22
Hemorrhage/Bleeding 18 18
Bacterial Infection 17 17
Foreign Body In Patient 14 14
Perforation of Esophagus 11 11
Stenosis 9 9
Unspecified Infection 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Injury 7 7
Burn, Thermal 5 5
Pneumonia 5 5
Rash 4 4
Perforation 4 4
Chest Pain 4 4
Death 4 4
Fever 4 4
Patient Problem/Medical Problem 4 4
Perforation of Vessels 4 4
Laceration(s) of Esophagus 4 4
Device Embedded In Tissue or Plaque 4 4
Pancreatitis 3 3
Burning Sensation 3 3
Burn(s) 3 3
Cardiac Arrest 3 4
Pain 3 3
Sepsis 3 3
Hypoxia 2 2
Inflammation 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Necrosis 2 2
Air Embolism 2 2
Hematoma 2 2
Hemoptysis 2 2
Dysphagia/ Odynophagia 2 2
Dyspnea 2 2
Shock 2 2
Tissue Damage 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Vaginal Mucosa Damage 2 2
Electric Shock 2 2
Respiratory Failure 2 2
Obstruction/Occlusion 2 2
Fibrosis 2 2
Gastroesophageal Burn 2 2
Hematemesis 1 1
Not Applicable 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
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
Skin Inflammation 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Respiratory Tract Infection 1 1
Rupture 1 1
Skin Tears 1 1
Bronchospasm 1 1
Fluid Discharge 1 1
Ventricular Tachycardia 1 1
Ulceration 1 1
Skin Irritation 1 1
Chills 1 1
Blurred Vision 1 1
Vomiting 1 1
Sedation 1 1
Sore Throat 1 1
Embolus 1 1
Purulent Discharge 1 1
Fistula 1 1
Headache 1 1
Arrhythmia 1 2
Aspiration/Inhalation 1 1
Abortion 1 1
Abrasion 1 1
Congenital Defect/Deformity 1 1
Conjunctivitis 1 1
Occlusion 1 1
Pleural Effusion 1 1
Seroma 1 1
Renal Failure 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 Dec-07-2018
8 Civco Medical Instruments Co. Inc. II Aug-29-2018
9 Civco Medical Instruments Co. Inc. II Aug-22-2018
10 DJO, LLC I Oct-05-2021
11 Exact Medical Manufacturing, Inc. II Jun-21-2021
12 GE Medical Systems, LLC II Dec-22-2022
13 Hitachi Medical Systems America Inc II Feb-20-2020
14 Hitachi Medical Systems America Inc II Mar-01-2018
15 Huntleigh Healthcare Ltd. II Apr-20-2022
16 Lumenis, Inc. I Nov-04-2021
17 Mac Medical Supply Co Inc I Sep-17-2021
18 National Distribution & Contracting Inc I Oct-13-2021
19 North Coast Medical Inc I Sep-29-2021
20 Olympus Corporation of the Americas II May-05-2022
21 Olympus Corporation of the Americas II Nov-27-2020
22 Philips Ultrasound Inc II May-01-2020
23 Philips Ultrasound, Inc. II Sep-06-2023
24 Red Medical Supplies I Oct-14-2021
25 Scrip Inc I Nov-17-2021
26 Verathon, Inc. II Dec-03-2020
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