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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 12 12
2021 5 5
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 5 5
Device Displays Incorrect Message 4 4
No Display/Image 3 3
Disconnection 1 1
Failure to Shut Off 1 1
Communication or Transmission Problem 1 1
Device Operational Issue 1 1
Positioning Failure 1 1
Failure to Align 1 1
Mechanics Altered 1 1
Optical Problem 1 1
Detachment of Device or Device Component 1 1
Erratic or Intermittent Display 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Self-Activation or Keying 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 2 2
Radiation Exposure, Unintended 1 1
Crushing Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America, LLC II Mar-13-2020
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