• 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
Regulation Description Radiologic table.
Product CodeKXJ
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 12 12
2018 31 31
2019 4 4
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 14 14
Fluid Leak 10 10
Mechanical Problem 9 9
Device Maintenance Issue 5 5
Lock 4 4
Table 4 4
Device Slipped 4 4
Device Operates Differently Than Expected 4 4
Hydraulic System 3 3
Mechanics Altered 3 3
Positioning Problem 3 3
Unintended System Motion 3 3
Detachment Of Device Component 2 2
Break 2 2
Locking Mechanism 1 1
Insufficient Information 1 1
Hydraulic Bed System 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Migration or Expulsion of Device 1 1
Controller 1 1
Unintended Arm Motion 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Device Displays Incorrect Message 1 1
Valve(s) 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21 21
No Patient Involvement 19 19
No Consequences Or Impact To Patient 5 5
Fall 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Injury 2 2
Head Injury 1 1
Pain 1 1
Not Applicable 1 1
No Information 1 1
No Code Available 1 1
Cerebrospinal Fluid Leakage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Mar-13-2018
2 GE Healthcare, LLC II Jun-10-2019
3 Villa Radiology Systems LLC II Jan-20-2017
4 Villa Radiology Systems LLC II Mar-06-2015
5 Villa Sistemi Medicali S.P.A. II Dec-31-2019
6 Villa Sistemi Medicali S.P.A. II Mar-09-2017
-
-