TPLC - Total Product Life Cycle

• Device: system, x-ray, mammographic
• Product Code: IZH
• Regulation Number: 892.1710
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
FUJI FILM MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GIOTTO USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC INC
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
IMS GIOTTO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL PRODUCTS INC.
	SUBSTANTIALLY EQUIVALENT	1
LORAD, A HOLOGIC CO.
	SUBSTANTIALLY EQUIVALENT	1
MACBRUD CORP., MEDICAL DIVISION
	SUBSTANTIALLY EQUIVALENT	1
PRECISION DYNAMICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WOMEN'S IMAGING SOLUTIONS ENTERPRISES LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	7	7
2015	8	8
2016	9	9
2017	12	12
2018	24	24
2019	39	39
2020	7	7
2021	9	9
2022	4	4
2023	8	8
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	37	37
Imprecision	12	12
Adverse Event Without Identified Device or Use Problem	9	9
Device Operational Issue	7	7
Poor Quality Image	7	7
Improper or Incorrect Procedure or Method	7	7
Signal Artifact/Noise	6	6
Break	5	5
Use of Device Problem	4	4
Device Operates Differently Than Expected	4	4
Output Problem	3	3
Unintended Movement	3	3
Failure to Align	3	3
Defective Device	2	2
Malposition of Device	2	2
Calibration Problem	2	2
Communication or Transmission Problem	2	2
Circuit Failure	2	2
Positioning Failure	2	2
Mechanical Problem	2	2
Decrease in Pressure	2	2
Device Fell	2	2
Device Contamination with Body Fluid	2	2
Optical Problem	1	1
Electrical Shorting	1	1
Facilities Issue	1	1
Flare or Flash	1	1
Installation-Related Problem	1	1
Maintenance Does Not Comply To Manufacturers Recommendations	1	1
Mechanics Altered	1	1
Unexpected Shutdown	1	1
Insufficient Information	1	1
Activation Failure	1	1
Positioning Problem	1	1
Power Problem	1	1
Increase in Pressure	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Rupture	1	1
Material Separation	1	1
Device Slipped	1	1
Moisture Damage	1	1
Nonstandard Device	1	1
Erratic or Intermittent Display	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Device Reprocessing Problem	1	1
Component Falling	1	1
Activation, Positioning or Separation Problem	1	1
Detachment of Device or Device Component	1	1
Application Program Problem	1	1
Device Or Device Fragments Location Unknown	1	1
Failure to Advance	1	1
Failure to Obtain Sample	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Air Leak	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	47	47
No Known Impact Or Consequence To Patient	20	20
Not Applicable	12	12
No Clinical Signs, Symptoms or Conditions	12	12
Pain	6	6
No Information	5	5
No Code Available	3	3
Radiation Exposure, Unintended	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Bruise/Contusion	3	3
Hematoma	2	2
Unspecified Infection	2	2
Perforation	2	2
Deformity/ Disfigurement	2	2
Skin Inflammation	2	2
Skin Tears	2	2
No Patient Involvement	2	2
Insufficient Information	2	2
Radiation Overdose	1	1
Device Embedded In Tissue or Plaque	1	1
Physical Entrapment	1	1
Discomfort	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Rash	1	1
Scar Tissue	1	1
Swelling	1	1
Tissue Damage	1	1
Burning Sensation	1	1
Itching Sensation	1	1
Laceration(s)	1	1
Hemorrhage/Bleeding	1	1
Burn(s)	1	1
Erythema	1	1
Fainting	1	1
Bone Fracture(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beekley Corporation	II	Jun-26-2015
2	Hologic, Inc.	II	Jun-03-2014