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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, medical examination, ac powered
Regulation Description AC-powered medical examination light.
Product CodeKZF
Regulation Number 880.6320
Device Class 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 70 71
2023 83 83
2024 20 20
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 145 146
Crack 75 75
Fracture 15 15
Break 9 9
Material Split, Cut or Torn 6 6
Device Fell 5 5
Peeled/Delaminated 4 4
Installation-Related Problem 4 4
Sparking 2 2
Fire 2 2
Insufficient Information 2 2
Smoking 2 2
Fitting Problem 1 1
Unintended Movement 1 1
Defective Component 1 1
Use of Device Problem 1 1
Component Missing 1 1
Flare or Flash 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Electromagnetic Interference 1 1
Corroded 1 1
Fluid/Blood Leak 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 191 192
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Superficial (First Degree) Burn 2 2
Insufficient Information 2 2
Bone Fracture(s) 1 1
Head Injury 1 1
Fall 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MRIMed Inc. II Feb-20-2026
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