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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device full field digital, system, x-ray, mammographic
Product CodeMUE
Regulation Number 892.1715
Device Class 2


Premarket Reviews
ManufacturerDecision
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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 132 132
Device Operational Issue 27 27
Break 16 16
Use of Device Problem 15 15
Unintended Movement 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Displays Incorrect Message 3 3
Unintended Collision 2 2
Mechanical Problem 2 2
Physical Resistance/Sticking 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Positioning Problem 2 2
Imprecision 2 2
Noise, Audible 1 1
Mechanical Jam 1 1
Improper or Incorrect Procedure or Method 1 1
Display or Visual Feedback Problem 1 1
Connection Problem 1 1
Fracture 1 1
Detachment of Device or Device Component 1 1
Retraction Problem 1 1
Product Quality Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Handling Problem 1 1
Data Problem 1 1
Calibration Problem 1 1
Structural Problem 1 1
Flare or Flash 1 1
Failure to Power Up 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Patient Data Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Material Erosion 1 1
Material Disintegration 1 1
Unintended Electrical Shock 1 1
Crack 1 1
Device Alarm System 1 1
Output Problem 1 1
Fire 1 1
Operating System Becomes Nonfunctional 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95 95
No Consequences Or Impact To Patient 83 83
Radiation Exposure, Unintended 24 24
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 6 6
Pain 4 4
Laceration(s) 3 3
Patient Problem/Medical Problem 2 2
Bone Fracture(s) 2 2
Syncope 1 1
Complaint, Ill-Defined 1 1
Electric Shock 1 1
No Code Available 1 1
Dizziness 1 1
No Information 1 1
Cardiac Arrest 1 1
Irritation 1 1
Injury 1 1
Fall 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Radiation Overdose 1 1
Skin Tears 1 1
Bruise/Contusion 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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