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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 6
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 1
SIEMENS MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 144 144
2019 80 80
2020 49 49
2021 25 25
2022 36 36
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 138 138
Device Operational Issue 94 94
Device Displays Incorrect Message 16 16
Use of Device Problem 13 13
Break 13 13
Unintended Movement 13 13
Poor Quality Image 10 10
Improper or Incorrect Procedure or Method 4 4
Device Stops Intermittently 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Detachment of Device or Device Component 3 3
Positioning Problem 2 2
Physical Resistance/Sticking 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Calibration Problem 2 2
Device Slipped 2 2
Device Emits Odor 2 2
Unintended Collision 2 2
Mechanical Problem 2 2
Imprecision 2 2
Crack 2 2
Material Disintegration 1 1
Erratic or Intermittent Display 1 1
Display or Visual Feedback Problem 1 1
Material Erosion 1 1
Fire 1 1
Fracture 1 1
Image Display Error/Artifact 1 1
Labelling, Instructions for Use or Training Problem 1 1
Thermal Decomposition of Device 1 1
Collapse 1 1
Device Alarm System 1 1
Smoking 1 1
Connection Problem 1 1
Flare or Flash 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Structural Problem 1 1
Defective Device 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Shielding Failure 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Operates Differently Than Expected 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Physical Property Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 101 101
Radiation Exposure, Unintended 90 90
No Clinical Signs, Symptoms or Conditions 64 64
Not Applicable 44 44
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 4 4
Pain 4 4
Bruise/Contusion 3 3
Fall 3 3
Bone Fracture(s) 2 2
No Information 2 2
Injury 2 2
Patient Problem/Medical Problem 2 2
Fracture, Arm 1 1
Complaint, Ill-Defined 1 1
No Code Available 1 1
Hematoma 1 1
Irritation 1 1
Laceration(s) 1 1
Dizziness 1 1
Radiation Overdose 1 1
Syncope 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II Feb-20-2018
2 Fujifilm Medical Systems U.S.A., Inc. II Jan-17-2018
3 GE Healthcare, LLC II Jul-30-2019
4 Hologic, Inc. II Feb-18-2020
5 Hologic, Inc. II Dec-27-2018
6 Siemens Medical Solutions USA, Inc II Jun-16-2020
7 Siemens Medical Solutions USA, Inc II Oct-18-2019
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