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TPLC
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Device
generator, high-voltage, x-ray, diagnostic
Product Code
IZO
Regulation Number
892.1700
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2017
2
2
2018
4
4
2019
2
2
2020
3
3
2022
1
1
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operational Issue
6
6
Fire
2
2
Image Display Error/Artifact
1
1
Power Conditioning Problem
1
1
Device Stops Intermittently
1
1
Device Inoperable
1
1
Use of Device Problem
1
1
Arcing
1
1
Device Operates Differently Than Expected
1
1
Mechanics Altered
1
1
Failure to Capture
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Radiation Exposure, Unintended
6
6
No Clinical Signs, Symptoms or Conditions
3
3
No Known Impact Or Consequence To Patient
3
3
Cardiac Arrest
1
1
Death
1
1
Bone Fracture(s)
1
1
No Consequences Or Impact To Patient
1
1
Electric Shock
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Shimadzu Medical Systems
II
Dec-23-2016
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