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TPLC
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Device
full field digital, system, x-ray, mammographic
Product Code
MUE
Regulation Number
892.1715
Device Class
2
Premarket Reviews
Manufacturer
Decision
DRTECH CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FUJIFILM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE
SUBSTANTIALLY EQUIVALENT
5
IMS GIOTTO S.P.A.
SUBSTANTIALLY EQUIVALENT
1
METALTRONICA SPA
SUBSTANTIALLY EQUIVALENT
1
PLANMED OY
SUBSTANTIALLY EQUIVALENT
2
RAYENCE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SIEMENS MEDICAL SOLUTIONS USA, INC.
SUBSTANTIALLY EQUIVALENT
2
VMI TECNOLOGIAS LTDA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
80
80
2020
49
49
2021
25
25
2022
36
36
2023
29
29
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended System Motion
125
125
Device Operational Issue
27
27
Break
16
16
Use of Device Problem
14
14
Adverse Event Without Identified Device or Use Problem
4
4
Unintended Movement
4
4
Device Displays Incorrect Message
3
3
No Apparent Adverse Event
2
2
Unintended Collision
2
2
Physical Resistance/Sticking
2
2
Insufficient Information
2
2
Mechanical Problem
2
2
Positioning Problem
2
2
Imprecision
2
2
Device Alarm System
1
1
Material Erosion
1
1
Crack
1
1
Display or Visual Feedback Problem
1
1
Output Problem
1
1
Defective Device
1
1
Labelling, Instructions for Use or Training Problem
1
1
Noise, Audible
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Device Slipped
1
1
Calibration Problem
1
1
Detachment of Device or Device Component
1
1
Device Contaminated During Manufacture or Shipping
1
1
Mechanical Jam
1
1
Device Handling Problem
1
1
Failure to Power Up
1
1
Patient Data Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Structural Problem
1
1
Retraction Problem
1
1
Connection Problem
1
1
Fracture
1
1
Operating System Becomes Nonfunctional
1
1
Unintended Electrical Shock
1
1
Material Disintegration
1
1
Product Quality Problem
1
1
Material Integrity Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Flare or Flash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
84
84
No Consequences Or Impact To Patient
83
83
Radiation Exposure, Unintended
24
24
No Known Impact Or Consequence To Patient
7
7
Insufficient Information
5
5
Pain
4
4
Patient Problem/Medical Problem
2
2
Electric Shock
1
1
No Information
1
1
Bruise/Contusion
1
1
Irritation
1
1
Fall
1
1
Skin Tears
1
1
Cardiac Arrest
1
1
Dizziness
1
1
Injury
1
1
Muscle/Tendon Damage
1
1
Radiation Overdose
1
1
Laceration(s)
1
1
Syncope
1
1
Complaint, Ill-Defined
1
1
Bone Fracture(s)
1
1
Unspecified Tissue Injury
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GE Healthcare, LLC
II
Jul-30-2019
2
GE Medical Systems, SCS
II
Feb-08-2024
3
Hologic, Inc.
II
Feb-18-2020
4
Siemens Medical Solutions USA, Inc
II
Jun-16-2020
5
Siemens Medical Solutions USA, Inc
II
Oct-18-2019
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