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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
2014 3 3
2016 1 1
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 4 4
Mechanical Problem 3 3
Fire 2 2
Detachment of Device or Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
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
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Poor Quality Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2
Physical Entrapment 1 1
Injury 1 1
Abrasion 1 1
Bruise/Contusion 1 1
No Code Available 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Aug-10-2022
2 GE Medical Systems, LLC II Nov-25-2009
3 Siemens Medical Solutions USA, Inc II Oct-30-2018
4 Siemens Medical Solutions USA, Inc II Apr-16-2014
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