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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital breast tomosynthesis
Definition To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Product CodeOTE
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 0 1 3 2 0

MDR Year MDR Reports MDR Events
2021 40 42
2022 58 58
2023 59 59
2024 130 130
2025 142 142
2026 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 369 369
Unintended Movement 23 23
Break 21 21
Adverse Event Without Identified Device or Use Problem 11 13
Fracture 8 8
Vibration 6 6
Poor Quality Image 4 4
Noise, Audible 4 4
Computer Software Problem 3 3
No Display/Image 2 2
Mechanical Problem 2 2
Device Emits Odor 2 2
Detachment of Device or Device Component 2 2
Appropriate Term/Code Not Available 2 2
Shielding Failure 2 2
Use of Device Problem 2 2
Sparking 2 2
Flare or Flash 2 2
Material Deformation 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Calibration Problem 1 1
Loss of Data 1 1
Missing Test Results 1 1
Insufficient Information 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Output below Specifications 1 1
Output Problem 1 1
Overheating of Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Failure to Obtain Sample 1 1
Arcing 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Crack 1 1
Material Disintegration 1 1
Patient Device Interaction Problem 1 1
Unintended Electrical Shock 1 1
Excessive Heating 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Key or Button Unresponsive/not Working 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 450 450
Insufficient Information 5 5
Laceration(s) 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Bone Fracture(s) 3 3
Cancer 3 3
Swollen Lymph Nodes/Glands 3 3
Abdominal Pain 2 2
Stroke/CVA 2 2
Death 2 4
Obstruction/Occlusion 2 2
Dyspnea 2 2
Pain 2 2
Swelling/ Edema 2 2
Ascites 2 2
Superficial (First Degree) Burn 1 1
Skin Infection 1 1
Electric Shock 1 1
Fatigue 1 1
Respiratory Arrest 1 1
Unspecified Gastrointestinal Problem 1 1
Abrasion 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Neck Pain 1 1
Needle Stick/Puncture 1 1
Discomfort 1 1
Ecchymosis 1 1
Bradycardia 1 1
Physical Entrapment 1 1
Asystole 1 1
Pulmonary Edema 1 1
Unspecified Tissue Injury 1 1
Skin Tears 1 1
Headache 1 1
Pulmonary Embolism 1 1
Bruise/Contusion 1 1
Breast Discomfort/Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 FUJIFILM Healthcare Americas Corporation II Jul-30-2025
2 Hologic Inc II Sep-25-2024
3 Hologic, Inc II May-12-2026
4 Hologic, Inc. II Feb-21-2023
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