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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device display, cathode-ray tube, medical
Regulation Description Medical cathode-ray tube display.
Product CodeDXJ
Regulation Number 870.2450
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND, GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENYANG TORCH-BIGTIDE DIGITAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 22 22
2021 6 10
2022 2 2
2023 17 17
2024 15 16
2025 3 3
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 11 11
Data Problem 9 9
No Audible Alarm 7 8
Computer Operating System Problem 7 7
Application Program Problem: Medication Error 6 6
Output Problem 4 4
Display or Visual Feedback Problem 4 4
Appropriate Term/Code Not Available 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
No Device Output 3 3
Erratic or Intermittent Display 3 3
Protective Measures Problem 2 2
Insufficient Information 2 2
Inaccurate Delivery 2 2
Failure to Transmit Record 2 2
Defective Device 2 2
Measurement System Incompatibility 2 2
Therapeutic or Diagnostic Output Failure 2 2
Patient Data Problem 2 2
Device Handling Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Inadequate User Interface 1 1
Intermittent Loss of Power 1 1
Device Displays Incorrect Message 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Power 1 5
Defective Alarm 1 1
Missing Information 1 1
Device Sensing Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Labelling, Instructions for Use or Training Problem 1 1
Date/Time-Related Software Problem 1 1
No Audible Prompt/Feedback 1 1
Use of Incorrect Control/Treatment Settings 1 1
Infusion or Flow Problem 1 1
Insufficient Flow or Under Infusion 1 1
Application Program Problem: Dose Calculation Error 1 1
Thermal Decomposition of Device 1 5
Use of Device Problem 1 1
Inaccurate Synchronization 1 1
Key or Button Unresponsive/not Working 1 1
Failure to Deliver 1 1
Wireless Communication Problem 1 1
Material Puncture/Hole 1 5
Application Program Problem 1 1
Image Display Error/Artifact 1 1
Device Alarm System 1 1
Communication or Transmission Problem 1 1
Break 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 47
No Known Impact Or Consequence To Patient 25 25
No Patient Involvement 8 8
No Consequences Or Impact To Patient 7 7
Insufficient Information 6 10
Death 2 2
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Drug Resistant Bacterial Infection 1 1
Injury 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
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