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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
Regulation Description Radiologic table.
Product CodeIXR
Regulation Number 892.1980
Device Class 2

MDR Year MDR Reports MDR Events
2016 58 58
2017 25 25
2018 17 17
2019 8 8
2020 12 12
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 34 34
Unintended Movement 19 19
Device Displays Incorrect Message 16 16
No Display/Image 10 10
Mechanical Problem 10 10
Device Inoperable 8 8
Self-Activation or Keying 6 6
Detachment Of Device Component 4 4
Positioning Problem 4 4
Loss of Power 4 4
Failure to Align 3 3
Device Stops Intermittently 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Poor Quality Image 2 2
Circuit Failure 2 2
Optical Problem 2 2
Device Operational Issue 2 2
Computer Operating System Problem 2 2
Failure to Power Up 2 2
Smoking 2 2
Failure to Shut Off 2 2
Noise, Audible 2 2
Mechanical Jam 1 1
Output Problem 1 1
Insufficient Information 1 1
Failure to Calibrate 1 1
Device Emits Odor 1 1
No Device Output 1 1
Difficult To Position 1 1
Positioning Failure 1 1
Difficult to Open or Close 1 1
Communication or Transmission Problem 1 1
Display or Visual Feedback Problem 1 1
Fluid Leak 1 1
Radiation Overexposure 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Loss of Data 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
High Readings 1 1
Unintended Collision 1 1
Unintended System Motion 1 1
Unable to Obtain Readings 1 1
Failure to Transmit Record 1 1
Device Remains Activated 1 1
Inadequate Service 1 1
Failure to Read Input Signal 1 1
Sticking 1 1
Disconnection 1 1
Erratic or Intermittent Display 1 1
Electrical /Electronic Property Problem 1 1
Leak/Splash 1 1
Device Maintenance Issue 1 1
Moisture Damage 1 1
Component Falling 1 1
Corroded 1 1
Device Alarm System 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 62 62
No Consequences Or Impact To Patient 38 38
No Patient Involvement 9 9
No Information 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Not Applicable 2 2
Radiation Exposure, Unintended 1 1
Head Injury 1 1
Complaint, Ill-Defined 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II May-22-2017
2 GE Healthcare, LLC II Dec-23-2016
3 LIEBEL-FLARSHEIM COMPANY LLC II Aug-21-2018
4 Oakworks Inc II May-23-2019
5 Oakworks Inc II Feb-23-2018
6 Philips Electronics North America Corporation II Aug-01-2016
7 Philips Medical Systems Nederlands II May-03-2018
8 Philips North America, LLC II Mar-13-2020
9 Philips North America, LLC II Mar-23-2019
10 Shimadzu Medical Systems II Apr-28-2016
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