TPLC - Total Product Life Cycle

• Device: table, radiologic
• Product Code: KXJ
• Regulation Number: 892.1980
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	31	31
2019	4	4
2020	2	2
2021	9	9
2022	50	50
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	38	38
Fluid/Blood Leak	27	27
Mechanical Problem	7	7
Device Maintenance Issue	5	5
Device Slipped	4	4
Device Operates Differently Than Expected	4	4
Insufficient Information	3	3
Break	3	3
Loose or Intermittent Connection	3	3
Mechanics Altered	3	3
Positioning Problem	2	2
Unintended System Motion	2	2
Use of Device Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
Signal Artifact/Noise	1	1
Migration or Expulsion of Device	1	1
Misconnection	1	1
Device Stops Intermittently	1	1
Device Inoperable	1	1
Solder Joint Fracture	1	1
Collapse	1	1
Decrease in Pressure	1	1
Leak/Splash	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	56	56
No Patient Involvement	19	19
No Known Impact Or Consequence To Patient	15	15
Insufficient Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Laceration(s)	2	2
No Consequences Or Impact To Patient	1	1
Not Applicable	1	1
Bruise/Contusion	1	1
No Information	1	1
Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Deerfield Imaging, Inc.	II	Sep-28-2021
2	Deerfield Imaging, Inc.	II	Mar-13-2018
3	GE Healthcare, LLC	II	Jun-10-2019
4	Villa Sistemi Medicali S.P.A.	II	Dec-31-2019