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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, radiographic, non-tilting, powered
Product CodeIZZ
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 2 2
2022 1 1
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 3 3
Fire 2 2
Labelling, Instructions for Use or Training Problem 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 2 2
Injury 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Aug-10-2022
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