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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
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 38 38
Fluid/Blood Leak 21 21
Positioning Failure 4 4
Insufficient Information 3 3
Loose or Intermittent Connection 3 3
Break 3 3
Difficult or Delayed Positioning 2 2
Unintended System Motion 2 2
Use of Device Problem 2 2
Solder Joint Fracture 1 1
Device Sensing Problem 1 1
Mechanical Jam 1 1
Therapeutic or Diagnostic Output Failure 1 1
Decrease in Pressure 1 1
Device Slipped 1 1
Misconnection 1 1
Signal Artifact/Noise 1 1
Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Known Impact Or Consequence To Patient 2 2
Laceration(s) 2 2
Pain 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 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
2 GE Healthcare, LLC II Jun-10-2019
3 Villa Sistemi Medicali S.P.A. II Dec-31-2019
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