TPLC - Total Product Life Cycle

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Device	display, cathode-ray tube, medical
Regulation Description	Medical cathode-ray tube display.
Product Code	DXJ
Regulation Number	870.2450
Device Class	2

Premarket Reviews
Manufacturer	Decision
LIVANOVA DEUTSCHLAND, GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	10	10
No Audible Alarm	6	7
Application Program Problem: Medication Error	4	4
Data Problem	3	3
Erratic or Intermittent Display	3	3
No Device Output	3	3
Insufficient Information	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Device Handling Problem	2	2
Display or Visual Feedback Problem	2	2
Leak/Splash	1	1
Failure to Read Input Signal	1	1
Unexpected Shutdown	1	1
Communication or Transmission Problem	1	1
Output Problem	1	1
Device Alarm System	1	1
Material Puncture/Hole	1	5
Defective Device	1	1
Failure to Deliver	1	1
Key or Button Unresponsive/not Working	1	1
Thermal Decomposition of Device	1	5
Infusion or Flow Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Date/Time-Related Software Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Defective Alarm	1	1
Inaccurate Delivery	1	1
Loss of Power	1	5
Intermittent Loss of Power	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	40	41
Insufficient Information	5	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Drug Resistant Bacterial Infection	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BARCO NV	II	Sep-29-2022
2	Barco N.V.	II	Jun-20-2025
3	Barco N.V.	II	Jul-11-2024
4	GE Healthcare, LLC	II	Jun-13-2022
5	GE Healthcare, LLC	II	Mar-16-2022
6	Wipro GE Healthcare Private Ltd.	II	Oct-21-2025