TPLC - Total Product Life Cycle

• Device: table, radiographic, tilting
• Product Code: IXR
• Regulation Number: 892.1980
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	8	8
2020	12	12
2021	5	5
2022	2	2
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	5	5
No Display/Image	4	4
Device Displays Incorrect Message	4	4
Self-Activation or Keying	2	2
Smoking	2	2
Failure to Align	1	1
Failure to Read Input Signal	1	1
Insufficient Information	1	1
Noise, Audible	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Communication or Transmission Problem	1	1
Loss of Data	1	1
Detachment of Device or Device Component	1	1
Device Operational Issue	1	1
Failure to Shut Off	1	1
Mechanical Jam	1	1
Mechanics Altered	1	1
Optical Problem	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Failure to Transmit Record	1	1
Thermal Decomposition of Device	1	1
Positioning Failure	1	1
Disconnection	1	1
Erratic or Intermittent Display	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	7	7
No Clinical Signs, Symptoms or Conditions	6	6
No Consequences Or Impact To Patient	5	5
Insufficient Information	4	4
No Patient Involvement	3	3
Radiation Exposure, Unintended	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Oakworks Inc	II	May-23-2019
2	Philips North America, LLC	II	Mar-13-2020
3	Philips North America, LLC	II	Mar-23-2019