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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
2020 2 2
2021 9 9
2022 50 50
2023 12 12
2024 8 8
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 43 43
Fluid/Blood Leak 19 19
Positioning Failure 5 5
Loose or Intermittent Connection 4 4
Break 3 3
Insufficient Information 3 3
Device Fell 3 3
Difficult or Delayed Positioning 3 3
Use of Device Problem 2 2
Device Sensing Problem 2 2
Power Problem 2 2
Unintended System Motion 2 2
Signal Artifact/Noise 1 1
Circuit Failure 1 1
Communication or Transmission Problem 1 1
Collapse 1 1
Failure to Interrogate 1 1
Failure to Sense 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem 1 1
Decrease in Pressure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Misconnection 1 1
Solder Joint Fracture 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Insufficient Information 3 3
Laceration(s) 2 2
Pain 1 1
Muscle/Tendon Damage 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-21-2025
2 Deerfield Imaging, Inc. II Sep-28-2021
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