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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, radiologic
Product CodeKXJ
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2018 31 31
2019 4 4
2020 2 2
2021 9 9
2022 50 50
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 43 43
Fluid/Blood Leak 29 29
Mechanical Problem 7 7
Device Maintenance Issue 5 5
Device Operates Differently Than Expected 4 4
Device Slipped 4 4
Positioning Failure 4 4
Loose or Intermittent Connection 4 4
Break 3 3
Mechanics Altered 3 3
Insufficient Information 3 3
Positioning Problem 2 2
Difficult or Delayed Positioning 2 2
Use of Device Problem 2 2
Unintended System Motion 2 2
Decrease in Pressure 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Solder Joint Fracture 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Signal Artifact/Noise 1 1
Collapse 1 1
Leak/Splash 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Sensing Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
No Patient Involvement 19 19
No Known Impact Or Consequence To Patient 15 15
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Laceration(s) 2 2
Muscle/Tendon Damage 1 1
No Consequences Or Impact To Patient 1 1
Not Applicable 1 1
No Information 1 1
Bruise/Contusion 1 1
Pain 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 Sistemi Medicali S.P.A. II Dec-31-2019
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