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 Code	MUE
Regulation Number	892.1715
Device Class	2

Premarket Reviews
Manufacturer	Decision
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	1
VIEWORKS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VMI TECNOLOGIAS LTDA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	109	109
Unintended Movement	12	12
Break	11	11
Adverse Event Without Identified Device or Use Problem	7	7
Device Operational Issue	5	5
Use of Device Problem	4	4
Detachment of Device or Device Component	4	4
Installation-Related Problem	3	3
Unintended Collision	3	3
Fire	2	2
Insufficient Information	2	2
Positioning Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Mechanical Jam	2	2
Sparking	1	1
Mechanical Problem	1	1
Physical Resistance/Sticking	1	1
Image Display Error/Artifact	1	1
Unintended Electrical Shock	1	1
Material Erosion	1	1
Device Fell	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Patient Data Problem	1	1
Failure to Power Up	1	1
Optical Problem	1	1
Data Problem	1	1
Device Handling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Fracture	1	1
Melted	1	1
Display or Visual Feedback Problem	1	1
Loose or Intermittent Connection	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	151
Insufficient Information	13	13
Laceration(s)	4	4
Bone Fracture(s)	3	3
Pain	2	2
Cancer	2	2
Abdominal Pain	1	1
Melena	1	1
Liver Failure	1	1
Electric Shock	1	1
Brain Injury	1	1
Fungal Infection	1	1
Radiation Exposure, Unintended	1	1
Dizziness	1	1
Head Injury	1	1
Cardiac Arrest	1	1
Intracranial Hemorrhage	1	1
Jaundice	1	1
Hematemesis	1	1
Muscle/Tendon Damage	1	1
Shock	1	1
Unspecified Tissue Injury	1	1
Hypoxia	1	1
Skin Tears	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	1	1
Cerebral Edema	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	Siemens Medical Solutions USA, Inc	II	Dec-03-2025