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TPLC
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Device
transducer, ultrasonic, diagnostic
Regulation Description
Diagnostic ultrasonic transducer.
Product Code
ITX
Regulation Number
892.1570
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
PARKER LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VITROLIFE SWEDEN AB
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
116
116
2021
146
146
2022
87
87
2023
145
145
2024
1000
1000
2025
161
161
Device Problems
MDRs with this Device Problem
Events in those MDRs
Poor Quality Image
870
870
Break
114
114
Adverse Event Without Identified Device or Use Problem
75
75
Leak/Splash
66
66
Fluid/Blood Leak
47
47
Material Twisted/Bent
46
46
Material Deformation
43
43
Deformation Due to Compressive Stress
33
33
No Display/Image
32
32
Detachment of Device or Device Component
30
30
Defective Component
29
29
Material Split, Cut or Torn
28
28
Failure to Clean Adequately
24
24
Device Contamination with Body Fluid
21
21
Stretched
18
18
Mechanical Problem
16
16
Mechanical Jam
15
15
Entrapment of Device
15
15
Material Integrity Problem
15
15
Material Separation
13
13
Data Problem
12
12
Defective Device
12
12
Material Puncture/Hole
12
12
Contamination /Decontamination Problem
11
11
Contamination
11
11
Output Problem
11
11
Improper or Incorrect Procedure or Method
9
9
No Apparent Adverse Event
9
9
Device Contamination with Chemical or Other Material
9
9
Scratched Material
9
9
Device Reprocessing Problem
8
8
Crack
8
8
Therapeutic or Diagnostic Output Failure
7
7
Nonstandard Device
7
7
Display or Visual Feedback Problem
6
6
Patient-Device Incompatibility
6
6
Positioning Problem
6
6
Patient Device Interaction Problem
6
6
Dent in Material
4
4
Failure to Advance
4
4
Image Display Error/Artifact
4
4
Application Program Freezes, Becomes Nonfunctional
4
4
Material Perforation
4
4
Microbial Contamination of Device
4
4
Material Discolored
3
3
Positioning Failure
3
3
Unable to Obtain Readings
3
3
Sharp Edges
3
3
Device Handling Problem
3
3
Gel Leak
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1405
1405
No Consequences Or Impact To Patient
76
76
No Known Impact Or Consequence To Patient
29
29
Insufficient Information
28
28
Pneumothorax
20
20
Hemorrhage/Bleeding
17
17
Foreign Body In Patient
15
15
No Patient Involvement
12
12
Bacterial Infection
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Infection
5
5
Burn, Thermal
5
5
Perforation of Vessels
4
4
Pneumonia
4
4
Rash
4
4
Fever
4
4
Pancreatitis
3
3
Sepsis
3
3
Perforation of Esophagus
3
3
Pain
3
3
Chest Pain
3
3
Laceration(s) of Esophagus
3
3
Device Embedded In Tissue or Plaque
2
2
Urinary Tract Infection
2
2
Respiratory Failure
2
2
Fibrosis
2
2
Hypoxia
2
2
Fluid Discharge
2
2
Laceration(s)
2
2
Urinary Retention
2
2
Burning Sensation
2
2
Vaginal Mucosa Damage
2
2
Cardiac Arrest
2
2
Obstruction/Occlusion
2
2
Itching Sensation
2
2
Air Embolism
2
2
Patient Problem/Medical Problem
2
2
Ectopic Pregnancy
2
2
Electric Shock
2
2
Gastroesophageal Burn
2
2
Hemoptysis
2
2
Vascular Dissection
2
2
Necrosis
2
2
Decreased Appetite
1
1
Skin Burning Sensation
1
1
Fistula
1
1
Embolus
1
1
Low Oxygen Saturation
1
1
Abortion
1
1
Syncope/Fainting
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
ImaCor Inc.
II
Oct-25-2024
13
Lumenis, Inc.
I
Nov-04-2021
14
Mac Medical Supply Co Inc
I
Sep-17-2021
15
National Distribution & Contracting Inc
I
Oct-13-2021
16
North Coast Medical Inc
I
Sep-29-2021
17
Olympus Corporation of the Americas
II
May-05-2022
18
Olympus Corporation of the Americas
II
Nov-27-2020
19
Philips Ultrasound Inc
II
May-01-2020
20
Philips Ultrasound, Inc.
II
Sep-06-2023
21
Red Medical Supplies
I
Oct-14-2021
22
Scrip Inc
I
Nov-17-2021
23
Verathon, Inc.
II
Dec-03-2020
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