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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device generator, high-voltage, x-ray, diagnostic
Regulation Description Diagnostic x-ray high voltage generator.
Product CodeIZO
Regulation Number 892.1700
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 4 4
2019 2 2
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 5 5
Mechanics Altered 1 1
Generator 1 1
Failure to Capture 1 1
Detachment Of Device Component 1 1
Component Falling 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 6 6
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1
Cardiac Arrest 1 1
Death 1 1
Bone Fracture(s) 1 1
Electric Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Shimadzu Medical Systems II Dec-23-2016
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