Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 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
Structural Problem 1 1
Retraction Problem 1 1
Therapeutic or Diagnostic Output Failure 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
Dizziness 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Skin Tears 1 1
Electric Shock 1 1
Radiation Overdose 1 1
Syncope 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Fall 1 1
Bone Fracture(s) 1 1
Irritation 1 1
Laceration(s) 1 1
No Information 1 1
No Code Available 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 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
-
-