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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, digital image storage, radiological
Regulation Description Medical image storage device.
Definition Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Product CodeLMB
Regulation Number 892.2010
Device Class 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 8 8
2021 10 10
2023 10 10
2024 9 9
2025 7 7
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Display or Visual Feedback Problem 17 17
No Display/Image 11 11
Computer Software Problem 3 3
Communication or Transmission Problem 2 2
Image Display Error/Artifact 2 2
Poor Quality Image 2 2
Defective Device 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Overheating of Device 2 2
Loss of Power 2 2
No Device Output 2 2
Reset Problem 1 1
Unexpected Shutdown 1 1
Break 1 1
Output Problem 1 1
Crack 1 1
Application Program Problem 1 1
Smoking 1 1
Application Program Problem: Dose Calculation Error 1 1
Power Problem 1 1
Loss of Data 1 1
Output below Specifications 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 3 3

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