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 table, radiologic
Product CodeKXJ
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 9 9
2022 50 50
2023 12 12
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 41 41
Fluid/Blood Leak 19 19
Positioning Failure 4 4
Break 3 3
Insufficient Information 3 3
Difficult or Delayed Positioning 3 3
Loose or Intermittent Connection 3 3
Use of Device Problem 2 2
Device Sensing Problem 2 2
Unintended System Motion 2 2
Signal Artifact/Noise 1 1
Communication or Transmission Problem 1 1
Collapse 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Decrease in Pressure 1 1
Misconnection 1 1
Solder Joint Fracture 1 1
Power Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 73
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Laceration(s) 2 2
Pain 1 1
Muscle/Tendon Damage 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Sep-28-2021
-
-