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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
Regulation Description Full-field digital mammography system.
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 2
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METALTRONICA SPA
  SUBSTANTIALLY EQUIVALENT 1
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIEWORKS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 25 25
2022 36 36
2023 29 29
2024 33 33
2025 40 40
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 114 114
Unintended Movement 14 14
Break 12 12
Device Operational Issue 6 6
Detachment of Device or Device Component 4 4
Unintended Collision 3 3
Installation-Related Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Fire 2 2
Use of Device Problem 2 2
Mechanical Problem 2 2
Mechanical Jam 2 2
Insufficient Device Problem Information 2 2
Material Erosion 1 1
Fracture 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Defective Component 1 1
Sparking 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Retraction Problem 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Data Problem 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 162 162
Insufficient Information 13 13
Laceration(s) 4 4
Pain 3 3
Bone Fracture(s) 3 3
Cancer 2 2
Deformity/ Disfigurement 1 1
Bruise/Contusion 1 1
Intracranial Hemorrhage 1 1
Dizziness 1 1
Scar Tissue 1 1
Low Blood Pressure/ Hypotension 1 1
Shock 1 1
Melena 1 1
Muscle/Tendon Damage 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Jaundice 1 1
Nodule 1 1
Radiation Exposure, Unintended 1 1
Skin Tears 1 1
Brain Injury 1 1
Fungal Infection 1 1
Cerebral Edema 1 1
Hypoxia 1 1
Hematemesis 1 1
Cardiac Arrest 1 1
Unspecified Tissue Injury 1 1
Electric Shock 1 1
Abdominal Pain 1 1
Head Injury 1 1
Liver Failure 1 1
Unspecified Infection 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems, LLC II Dec-09-2025
2 GE Medical Systems, SCS II Feb-08-2024
3 Hologic, Inc II May-12-2026
4 Siemens Medical Solutions USA, Inc II Dec-03-2025
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