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
2014	120	120
2015	82	82
2016	58	58
2017	25	25
2018	17	17
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
Device Operates Differently Than Expected	143	143
Device Displays Incorrect Message	32	32
Device Inoperable	30	30
No Display/Image	25	25
Unintended Movement	24	24
Mechanical Problem	18	18
Loss of Power	10	10
Detachment Of Device Component	9	9
Computer Operating System Problem	9	9
Failure to Align	7	7
Self-Activation or Keying	7	7
Positioning Problem	7	7
Poor Quality Image	5	5
Failure to Power Up	4	4
Component Falling	4	4
Noise, Audible	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Operational Issue	3	3
Difficult to Open or Close	3	3
Communication or Transmission Problem	3	3
Smoking	3	3
Sticking	3	3
Device Stops Intermittently	3	3
Application Interface Becomes Non-Functional Or Program Exits Abnormally	3	3
Output Problem	3	3
Circuit Failure	2	2
Device Remains Activated	2	2
Unintended Collision	2	2
Unintended System Motion	2	2
No Device Output	2	2
Overheating of Device	2	2
Difficult To Position	2	2
Failure to Shut Off	2	2
Improper Device Output	2	2
Mechanical Jam	2	2
Detachment of Device or Device Component	2	2
Optical Problem	2	2
Programming Issue	2	2
Radiation Overexposure	1	1
Power Problem	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Insufficient Information	1	1
Operating System Becomes Nonfunctional	1	1
Mechanics Altered	1	1
Malposition of Device	1	1
Application Program Problem	1	1
Loss of Data	1	1
Inadequate Service	1	1
Failure to Read Input Signal	1	1
Device Slipped	1	1
Unstable	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Calibrate	1	1
High Test Results	1	1
High Readings	1	1
Moisture Damage	1	1
Device Alarm System	1	1
Thermal Decomposition of Device	1	1
Device Emits Odor	1	1
Unable to Obtain Readings	1	1
Failure to Transmit Record	1	1
Positioning Failure	1	1
Disconnection	1	1
Erratic or Intermittent Display	1	1
Computer Software Problem	1	1
Corroded	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Entrapment of Device	1	1
Fire	1	1
Fluid/Blood Leak	1	1
Excess Flow or Over-Infusion	1	1
Leak/Splash	1	1
Device Maintenance Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	147	147
No Known Impact Or Consequence To Patient	143	143
No Patient Involvement	14	14
No Information	10	10
No Clinical Signs, Symptoms or Conditions	6	6
Insufficient Information	4	4
Not Applicable	2	2
Injury	2	2
Neck Pain	1	1
Complaint, Ill-Defined	1	1
Fall	1	1
Head Injury	1	1
Pain	1	1
Thrombosis	1	1
Radiation Exposure, Unintended	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	Medical Positioning Inc	II	Apr-13-2011
5	Oakworks Inc	II	May-23-2019
6	Oakworks Inc	II	Feb-23-2018
7	Philips Electronics North America Corporation	II	Aug-01-2016
8	Philips Healthcare Inc.	II	Aug-15-2012
9	Philips Healthcare Inc.	II	Jun-18-2012
10	Philips Medical Systems Nederlands	II	May-03-2018
11	Philips Medical Systems North America Co. Phillips	II	Sep-13-2010
12	Philips Medical Systems North America Co. Phillips	II	Mar-23-2010
13	Philips North America, LLC	II	Mar-13-2020
14	Philips North America, LLC	II	Mar-23-2019
15	Shimadzu Medical Systems	II	Apr-28-2016
16	Toshiba American Medical Systems Inc	II	Mar-16-2011