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	3
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
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	107	107
Break	13	13
Use of Device Problem	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Unintended Movement	5	5
Insufficient Information	3	3
Device Operational Issue	3	3
Positioning Problem	2	2
Unintended Collision	2	2
Mechanical Problem	2	2
Device Handling Problem	2	2
No Apparent Adverse Event	2	2
Fire	2	2
Device Displays Incorrect Message	1	1
Material Integrity Problem	1	1
Display or Visual Feedback Problem	1	1
Patient Data Problem	1	1
Material Erosion	1	1
Device Fell	1	1
Crack	1	1
Material Disintegration	1	1
Device Alarm System	1	1
Data Problem	1	1
Melted	1	1
Unintended Electrical Shock	1	1
Output Problem	1	1
Physical Resistance/Sticking	1	1
Labelling, Instructions for Use or Training Problem	1	1
Failure to Power Up	1	1
Structural Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Noise, Audible	1	1
Mechanical Jam	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Fracture	1	1
Detachment of Device or Device Component	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	110	110
No Consequences Or Impact To Patient	35	35
Insufficient Information	7	7
Laceration(s)	4	4
Pain	3	3
No Known Impact Or Consequence To Patient	3	3
Bone Fracture(s)	3	3
Radiation Exposure, Unintended	2	2
Irritation	1	1
Dizziness	1	1
Complaint, Ill-Defined	1	1
Skin Tears	1	1
Electric Shock	1	1
No Information	1	1
Syncope	1	1
Bruise/Contusion	1	1
Cardiac Arrest	1	1
Fall	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Medical Systems, SCS	II	Feb-08-2024
2	Hologic, Inc.	II	Feb-18-2020
3	Siemens Medical Solutions USA, Inc	II	Jun-16-2020