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TPLC
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Device
system, x-ray, mammographic
Product Code
IZH
Regulation Number
892.1710
Device Class
2
Premarket Reviews
Manufacturer
Decision
FUJIFILM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
HOLOGIC, INC
SUBSTANTIALLY EQUIVALENT
1
IMS GIOTTO S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
24
24
2019
39
39
2020
7
7
2021
9
9
2022
4
4
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended System Motion
37
37
Imprecision
12
12
Device Operational Issue
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Unintended Movement
3
3
Device Fell
2
2
Poor Quality Image
2
2
Device Contamination with Body Fluid
2
2
Defective Device
2
2
Malposition of Device
2
2
Calibration Problem
2
2
Break
2
2
Circuit Failure
2
2
Positioning Failure
2
2
Erratic or Intermittent Display
1
1
Increase in Pressure
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Separation
1
1
Improper or Incorrect Procedure or Method
1
1
Communication or Transmission Problem
1
1
Detachment of Device or Device Component
1
1
Application Program Problem
1
1
Failure to Obtain Sample
1
1
Loose or Intermittent Connection
1
1
Moisture Damage
1
1
Unexpected Shutdown
1
1
Activation Failure
1
1
Optical Problem
1
1
Output Problem
1
1
Positioning Problem
1
1
Power Problem
1
1
Electrical Shorting
1
1
Flare or Flash
1
1
Installation-Related Problem
1
1
Mechanics Altered
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
44
44
No Clinical Signs, Symptoms or Conditions
12
12
Not Applicable
9
9
No Known Impact Or Consequence To Patient
6
6
Radiation Exposure, Unintended
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Insufficient Information
2
2
Skin Tears
2
2
Bruise/Contusion
2
2
Pain
2
2
Perforation
2
2
Scar Tissue
1
1
Tissue Damage
1
1
Fainting
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Unspecified Infection
1
1
No Patient Involvement
1
1
Deformity/ Disfigurement
1
1
Skin Inflammation
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
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