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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, radiographic, stationary top
Product CodeIXQ
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 1 1
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Issue 1 1
Break 1 1
Insufficient Information 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Operates Differently Than Expected 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Cardiac Arrest 1 1
Death 1 1
Bone Fracture(s) 1 1
Hemoptysis 1 1
Hemorrhage/Bleeding 1 1
Toxicity 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Civco Medical Instruments Inc II Aug-15-2011
2 Med Tec Inc II Nov-16-2010
3 Med Tec Inc III Aug-20-2009
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