TPLC - Total Product Life Cycle

• Device: system, x-ray, angiographic
• Product Code: IZI
• Regulation Number: 892.1600
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTERYFLOW TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT - WITH DRUG	1
CARL ZEISS MEDITEC INC
	SUBSTANTIALLY EQUIVALENT	1
LEICA MICROSYSTEMS (SCHWEIZ) AG
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1
NOVADAQ TECHNOLOGIES ULC (A PART OF STRYKER)
	SUBSTANTIALLY EQUIVALENT	1
NOVADAQ TECHNOLOGIES ULC. (NOW A PART OF STRYKER)
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ONLUME INC.
	SUBSTANTIALLY EQUIVALENT	1
PIE MEDICAL IMAGING BV
	SUBSTANTIALLY EQUIVALENT	1
SURGVISION GMBH
	SUBSTANTIALLY EQUIVALENT	3
SYNAPTIVE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	88	88
2018	49	49
2019	30	30
2020	14	14
2021	29	29
2022	264	264
2023	1198	1198
2024	512	512

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	850	850
Radiation Output Failure	639	639
Positioning Failure	269	269
No Display/Image	156	156
Insufficient Information	55	55
Unintended System Motion	19	19
Detachment of Device or Device Component	18	18
Smoking	15	15
Failure to Power Up	12	12
No Device Output	12	12
Device Operates Differently Than Expected	12	12
Adverse Event Without Identified Device or Use Problem	12	12
No Apparent Adverse Event	11	11
Device Displays Incorrect Message	11	11
Erratic or Intermittent Display	11	11
Difficult or Delayed Activation	10	10
Output Problem	9	9
Image Display Error/Artifact	9	9
Unexpected Shutdown	9	9
Poor Quality Image	6	6
Unintended Movement	6	6
Radiation Overexposure	6	6
Use of Device Problem	6	6
Positioning Problem	5	5
Fire	5	5
Overheating of Device	5	5
Display or Visual Feedback Problem	5	5
Break	5	5
Fluid/Blood Leak	4	4
Mechanical Jam	4	4
Defective Device	4	4
Missing Value Reason	4	4
Physical Resistance/Sticking	4	4
Device Fell	3	3
Noise, Audible	3	3
Device Inoperable	3	3
Device Operational Issue	3	3
Device Dislodged or Dislocated	3	3
Radiation Underexposure	3	3
Entrapment of Device	3	3
Loss of Power	3	3
Computer Software Problem	3	3
Thermal Decomposition of Device	2	2
Difficult or Delayed Positioning	2	2
Output above Specifications	2	2
Device Emits Odor	2	2
Temperature Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Operating System Becomes Nonfunctional	2	2
Failure to Read Input Signal	2	2
Defective Component	2	2
Failure to Advance	2	2
Computer Operating System Problem	2	2
Data Back-Up Problem	2	2
Unexpected/Unintended Radiation Output	2	2
Air/Gas in Device	2	2
Data Problem	2	2
Appropriate Term/Code Not Available	2	2
Radiation Output Problem	2	2
Intermittent Loss of Power	1	1
Unintended Electrical Shock	1	1
Key or Button Unresponsive/not Working	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Intermittent Energy Output	1	1
Loss of Data	1	1
Device Tipped Over	1	1
Sparking	1	1
Malposition of Device	1	1
Application Program Problem	1	1
Contamination /Decontamination Problem	1	1
Communication or Transmission Problem	1	1
Separation Failure	1	1
Component Missing	1	1
Structural Problem	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Visual Prompts will not Clear	1	1
Optical Distortion	1	1
Naturally Worn	1	1
Failure to Auto Stop	1	1
Failure to Shut Off	1	1
Device Contamination with Chemical or Other Material	1	1
Energy Output Problem	1	1
Nonstandard Device	1	1
Difficult To Position	1	1
Repair	1	1
Failure to Reset	1	1
Inaccurate Synchronization	1	1
Emergency Power Failure	1	1
Image Orientation Incorrect	1	1
Image Resolution Poor	1	1
Imprecision	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Contamination	1	1
Crack	1	1
Disconnection	1	1
Display Difficult to Read	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1968	1968
No Known Impact Or Consequence To Patient	86	86
No Consequences Or Impact To Patient	34	34
Insufficient Information	30	30
No Information	9	9
No Code Available	8	8
Death	7	7
Fall	6	6
Burn(s)	6	6
Laceration(s)	6	6
Injury	6	6
Hair Loss	5	5
Pain	4	4
Radiation Overdose	4	4
No Patient Involvement	4	4
Radiation Exposure, Unintended	3	3
Bruise/Contusion	3	3
Crushing Injury	3	3
Electric Shock	2	2
Myocardial Infarction	2	2
Cardiac Arrest	2	2
Hemorrhage/Bleeding	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Not Applicable	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Head Injury	1	1
Hematoma	1	1
Paresis	1	1
Skull Fracture	1	1
Ventricular Fibrillation	1	1
Ventricular Tachycardia	1	1
Bone Fracture(s)	1	1
Radiation Burn	1	1
Aneurysm	1	1
Overdose	1	1
Hemorrhagic Stroke	1	1
Ruptured Aneurysm	1	1
Reaction	1	1
Obstruction/Occlusion	1	1
Skin Tears	1	1
Brain Injury	1	1
Discharge	1	1
Complaint, Ill-Defined	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare, LLC	II	Apr-18-2019
2	Philips Electronics North America Corporation	II	Sep-21-2018
3	Philips Electronics North America Corporation	II	Jan-20-2017
4	Philips Electronics North America Corporation	II	Jan-20-2017
5	Philips Medical Systems Nederlands	II	Apr-13-2019
6	Philips Medical Systems Nederlands	II	May-03-2018
7	Philips North America, LLC	II	Mar-13-2020
8	Philips North America, LLC	II	Mar-23-2019
9	Shimadzu Medical Systems	II	Feb-28-2022
10	Shimadzu Medical Systems	II	Dec-10-2020
11	Shimadzu Medical Systems	II	Jun-14-2018
12	Shimadzu Medical Systems Usa Com	II	Feb-27-2019
13	Siemens Medical Solutions USA, Inc	II	May-15-2019
14	Siemens Medical Solutions USA, Inc	II	Dec-05-2018
15	Siemens Medical Solutions USA, Inc	II	Nov-14-2018
16	Siemens Medical Solutions USA, Inc	II	Feb-23-2018
17	Siemens Medical Solutions USA, Inc	II	Aug-29-2017
18	Siemens Medical Solutions USA, Inc	II	Jul-14-2017
19	Siemens Medical Solutions USA, Inc	II	Mar-30-2017
20	Siemens Medical Solutions USA, Inc	II	Mar-14-2017