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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, x-ray, angiographic
Regulation Description Angiographic x-ray system.
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
ONLUME INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGVISION GMBH
  SUBSTANTIALLY EQUIVALENT 3
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 14 14
2021 29 29
2022 264 264
2023 1198 1198
2024 1317 1317
2025 347 347

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1374 1374
Radiation Output Failure 1048 1048
Positioning Failure 407 407
No Display/Image 213 213
Detachment of Device or Device Component 20 20
Unintended System Motion 19 19
Smoking 15 15
Unexpected Shutdown 14 14
No Device Output 12 12
Erratic or Intermittent Display 12 12
Difficult or Delayed Activation 11 11
Failure to Power Up 10 10
Output Problem 8 8
Image Display Error/Artifact 7 7
Insufficient Information 7 7
Display or Visual Feedback Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Device Operational Issue 4 4
Poor Quality Image 4 4
Radiation Underexposure 3 3
Radiation Output Problem 3 3
Break 3 3
Mechanical Jam 3 3
Fire 3 3
Physical Resistance/Sticking 3 3
Device Dislodged or Dislocated 3 3
Unintended Movement 3 3
Computer Software Problem 3 3
Defective Device 3 3
Radiation Overexposure 3 3
Temperature Problem 2 2
Fluid/Blood Leak 2 2
Unexpected/Unintended Radiation Output 2 2
Image Orientation Incorrect 2 2
Appropriate Term/Code Not Available 2 2
Failure to Advance 2 2
No Apparent Adverse Event 2 2
Data Problem 2 2
Difficult or Delayed Positioning 2 2
Key or Button Unresponsive/not Working 2 2
Air/Gas in Device 2 2
Malposition of Device 2 2
Entrapment of Device 2 2
Visual Prompts will not Clear 1 1
Imprecision 1 1
Use of Device Problem 1 1
Gas/Air Leak 1 1
Structural Problem 1 1
Optical Distortion 1 1
Output above Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3103 3103
Insufficient Information 54 54
No Consequences Or Impact To Patient 9 9
Fall 7 7
No Known Impact Or Consequence To Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pain 4 4
Laceration(s) 3 3
Crushing Injury 2 2
Radiation Overdose 2 2
Hemorrhage/Bleeding 2 2
Brain Injury 1 1
Skull Fracture 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Hematoma 1 1
Obstruction/Occlusion 1 1
Hemorrhagic Stroke 1 1
Cardiac Arrest 1 1
Hair Loss 1 1
Paresis 1 1
Myocardial Infarction 1 1
Skin Tears 1 1
Ruptured Aneurysm 1 1
Low Blood Pressure/ Hypotension 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America, LLC II Mar-13-2020
2 Shimadzu Medical Systems II Feb-28-2022
3 Shimadzu Medical Systems II Dec-10-2020
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