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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2016 1 1
2017 12 12
2018 31 31
2019 4 4
2020 2 2
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 15 15
Fluid Leak 11 11
Mechanical Problem 9 9
Device Maintenance Issue 5 5
Unintended System Motion 4 4
Device Slipped 4 4
Device Operates Differently Than Expected 4 4
Insufficient Information 4 4
Mechanics Altered 3 3
Positioning Problem 3 3
Use of Device Problem 2 2
Break 2 2
Collapse 1 1
Detachment Of Device Component 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Unintended Arm Motion 1 1
Migration or Expulsion of Device 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Decrease in Pressure 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
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Pain 1 1
Bruise/Contusion 1 1
Cerebrospinal Fluid Leakage 1 1
Fall 1 1
Not Applicable 1 1
No Information 1 1
No Code Available 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Sep-28-2021
2 Deerfield Imaging, Inc. II Mar-13-2018
3 GE Healthcare, LLC II Jun-10-2019
4 Villa Radiology Systems LLC II Jan-20-2017
5 Villa Sistemi Medicali S.P.A. II Dec-31-2019
6 Villa Sistemi Medicali S.P.A. II Mar-09-2017
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