Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
LEICA MICROSYSTEMS (SCHWEIZ) AG
  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 2

MDR Year MDR Reports MDR Events
2018 49 49
2019 30 30
2020 14 14
2021 29 29
2022 265 265
2023 218 218

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 187 187
Radiation Output Failure 141 141
Positioning Failure 60 60
No Display/Image 54 54
Insufficient Information 28 28
Smoking 11 11
Unintended System Motion 10 10
No Device Output 10 10
Detachment of Device or Device Component 7 7
Image Display Error/Artifact 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Use of Device Problem 5 5
Unintended Movement 5 5
Failure to Power Up 5 5
Unexpected Shutdown 4 4
Physical Resistance/Sticking 4 4
Poor Quality Image 4 4
Break 4 4
Defective Device 4 4
Erratic or Intermittent Display 4 4
Difficult or Delayed Activation 4 4
Device Displays Incorrect Message 4 4
Radiation Overexposure 3 3
Device Fell 3 3
Noise, Audible 3 3
Output Problem 3 3
Mechanical Jam 3 3
Loss of Power 2 2
Temperature Problem 2 2
Display or Visual Feedback Problem 2 2
Overheating of Device 2 2
Entrapment of Device 2 2
Failure to Read Input Signal 2 2
Device Inoperable 2 2
Failure to Advance 2 2
Fire 2 2
Device Operates Differently Than Expected 2 2
Device Operational Issue 2 2
Operating System Becomes Nonfunctional 2 2
Difficult or Delayed Positioning 2 2
Device Dislodged or Dislocated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 1 1
Structural Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Key or Button Unresponsive/not Working 1 1
Contamination /Decontamination Problem 1 1
Data Back-Up Problem 1 1
Communication or Transmission Problem 1 1
Loss of Data 1 1
Defective Component 1 1
Unexpected/Unintended Radiation Output 1 1
Data Problem 1 1
Energy Output Problem 1 1
Loose or Intermittent Connection 1 1
Radiation Underexposure 1 1
Emergency Power Failure 1 1
Computer Software Problem 1 1
Disconnection 1 1
Difficult To Position 1 1
Fluid/Blood Leak 1 1
Failure to Shut Off 1 1
Naturally Worn 1 1
Missing Value Reason 1 1
Computer Operating System Problem 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 484 484
No Known Impact Or Consequence To Patient 55 55
Insufficient Information 17 17
No Consequences Or Impact To Patient 14 14
Laceration(s) 5 5
Fall 5 5
No Information 4 4
No Code Available 4 4
Radiation Overdose 3 3
Hair Loss 3 3
Pain 3 3
Injury 3 3
Cardiac Arrest 2 2
Crushing Injury 2 2
Electric Shock 2 2
Bruise/Contusion 2 2
Hemorrhage/Bleeding 2 2
Radiation Exposure, Unintended 2 2
Death 2 2
Bone Fracture(s) 1 1
Brain Injury 1 1
Paresis 1 1
Hemorrhagic Stroke 1 1
Skull Fracture 1 1
Reaction 1 1
No Patient Involvement 1 1
Obstruction/Occlusion 1 1
Hematoma 1 1
Skin Tears 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Head Injury 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 Medical Systems Nederlands II Apr-13-2019
4 Philips Medical Systems Nederlands II May-03-2018
5 Philips North America, LLC II Mar-13-2020
6 Philips North America, LLC II Mar-23-2019
7 Shimadzu Medical Systems II Feb-28-2022
8 Shimadzu Medical Systems II Dec-10-2020
9 Shimadzu Medical Systems II Jun-14-2018
10 Shimadzu Medical Systems Usa Com II Feb-27-2019
11 Siemens Medical Solutions USA, Inc II May-15-2019
12 Siemens Medical Solutions USA, Inc II Dec-05-2018
13 Siemens Medical Solutions USA, Inc II Nov-14-2018
14 Siemens Medical Solutions USA, Inc II Feb-23-2018
-
-