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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, x-ray, intraoral
Product CodeEAP
Regulation Number 872.1810
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1
2022 2 2
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Image Display Error/Artifact 12 12
Detachment of Device or Device Component 3 3
Device Operational Issue 2 2
Installation-Related Problem 1 1
Material Twisted/Bent 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Known Impact Or Consequence To Patient 2 2
Radiation Exposure, Unintended 1 1

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