• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 2

MDR Year MDR Reports MDR Events
2019 30 30
2020 14 14
2021 29 29
2022 264 264
2023 1198 1198
2024 185 185

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 707 707
Radiation Output Failure 505 505
Positioning Failure 238 238
No Display/Image 137 137
Unintended System Motion 17 17
Detachment of Device or Device Component 15 15
No Device Output 12 12
Smoking 11 11
Difficult or Delayed Activation 10 10
Erratic or Intermittent Display 10 10
Output Problem 9 9
Unexpected Shutdown 9 9
Failure to Power Up 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
Noise, Audible 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Mechanical Jam 3 3
Radiation Overexposure 3 3
Radiation Underexposure 3 3
Break 3 3
Defective Device 3 3
Device Dislodged or Dislocated 3 3
Failure to Read Input Signal 2 2
Failure to Advance 2 2
Use of Device Problem 2 2
Computer Software Problem 2 2
Difficult or Delayed Positioning 2 2
Entrapment of Device 2 2
Fire 2 2
Fluid/Blood Leak 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unexpected/Unintended Radiation Output 2 2
Air/Gas in Device 2 2
Data Problem 2 2
Key or Button Unresponsive/not Working 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Energy Output 1 1
Naturally Worn 1 1
Operating System Becomes Nonfunctional 1 1
Optical Distortion 1 1
Intermittent Loss of Power 1 1
Appropriate Term/Code Not Available 1 1
Emergency Power Failure 1 1
Disconnection 1 1
Display Difficult to Read 1 1
Device Emits Odor 1 1
Image Orientation Incorrect 1 1
Imprecision 1 1
Overheating of Device 1 1
Loss of Power 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
Separation Failure 1 1
Failure to Shut Off 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 1640 1640
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
-
-