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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, angiographic
Product CodeIZI
Regulation Number 892.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTERYFLOW TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 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
SURGVISION GMBH
  SUBSTANTIALLY EQUIVALENT 3
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 14 14
2021 29 29
2022 264 264
2023 1198 1198
2024 435 435

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 817 817
Radiation Output Failure 610 610
Positioning Failure 262 262
No Display/Image 147 147
Unintended System Motion 18 18
Detachment of Device or Device Component 16 16
No Device Output 12 12
Smoking 12 12
Erratic or Intermittent Display 11 11
Difficult or Delayed Activation 10 10
Failure to Power Up 9 9
Unexpected Shutdown 9 9
Output Problem 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Image Display Error/Artifact 6 6
Poor Quality Image 5 5
Display or Visual Feedback Problem 5 5
Insufficient Information 5 5
Unintended Movement 4 4
Device Dislodged or Dislocated 3 3
Mechanical Jam 3 3
Noise, Audible 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Radiation Overexposure 3 3
Radiation Underexposure 3 3
Break 3 3
Fire 3 3
Defective Device 3 3
Failure to Advance 2 2
Failure to Read Input Signal 2 2
Use of Device Problem 2 2
Fluid/Blood Leak 2 2
Computer Software Problem 2 2
Difficult or Delayed Positioning 2 2
Entrapment of Device 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Radiation Output Problem 2 2
Unexpected/Unintended Radiation Output 2 2
Appropriate Term/Code Not Available 2 2
Data Problem 2 2
Air/Gas in Device 2 2
Key or Button Unresponsive/not Working 1 1
Intermittent Energy Output 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Loss of Power 1 1
Naturally Worn 1 1
Failure to Shut Off 1 1
Operating System Becomes Nonfunctional 1 1
Optical Distortion 1 1
Positioning Problem 1 1
Emergency Power Failure 1 1
Disconnection 1 1
Display Difficult to Read 1 1
Image Orientation Incorrect 1 1
Imprecision 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
Visual Prompts will not Clear 1 1
Defective Component 1 1
Component Missing 1 1
Structural Problem 1 1
Overheating of Device 1 1
Loss of Power 1 1
Separation Failure 1 1
Device Operational Issue 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Data Back-Up Problem 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1893 1893
Insufficient Information 29 29
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 11 11
Laceration(s) 5 5
Fall 5 5
Hair Loss 4 4
Pain 4 4
No Code Available 3 3
Radiation Overdose 3 3
Bruise/Contusion 2 2
Crushing Injury 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemorrhagic Stroke 1 1
Ruptured Aneurysm 1 1
Paresis 1 1
Skull Fracture 1 1
Radiation Exposure, Unintended 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1
Brain Injury 1 1
Injury 1 1
Obstruction/Occlusion 1 1
Skin Tears 1 1
Cardiac Arrest 1 1
Head Injury 1 1
Hematoma 1 1
Bone Fracture(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Apr-18-2019
2 Philips Medical Systems Nederlands II Apr-13-2019
3 Philips North America, LLC II Mar-13-2020
4 Philips North America, LLC II Mar-23-2019
5 Shimadzu Medical Systems II Feb-28-2022
6 Shimadzu Medical Systems II Dec-10-2020
7 Shimadzu Medical Systems Usa Com II Feb-27-2019
8 Siemens Medical Solutions USA, Inc II May-15-2019
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