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TPLC
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show TPLC since
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Device
display, cathode-ray tube, medical
Product Code
DXJ
Regulation Number
870.2450
Device Class
2
Premarket Reviews
Manufacturer
Decision
BARCO N.V.
SUBSTANTIALLY EQUIVALENT
4
BARCO NV
SUBSTANTIALLY EQUIVALENT
1
EIZO GMBH
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
LIVANOVA DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
1
MEDUSA MEDICAL TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
PERKINS HEALTHCARE TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
3
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
SUBSTANTIALLY EQUIVALENT
1
SHENYANG TORCH-BIGTIDE DIGITAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SORIN GROUP DEUTSCHLAND GMBH
SUBSTANTIALLY EQUIVALENT
2
ST. JUDE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
VIOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ZOLL MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
15
15
2016
6
6
2017
10
10
2018
3
3
2019
29
29
2020
22
22
2021
6
6
2022
2
2
2023
17
17
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
16
16
Data Problem
10
10
Application Program Problem: Medication Error
8
8
Computer Operating System Problem
7
7
Device Operates Differently Than Expected
6
6
No Audible Alarm
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Improper or Incorrect Procedure or Method
4
4
Output Problem
4
4
Appropriate Term/Code Not Available
4
4
Patient Data Problem
3
3
Erratic or Intermittent Display
3
3
Inaccurate Delivery
3
3
No Device Output
3
3
Display or Visual Feedback Problem
3
3
Application Program Problem: Dose Calculation Error
2
2
Fracture
2
2
Unsealed Device Packaging
2
2
Tear, Rip or Hole in Device Packaging
2
2
Low Readings
2
2
Failure to Disconnect
2
2
Device Displays Incorrect Message
2
2
Device Alarm System
2
2
Failure to Transmit Record
2
2
Use of Device Problem
2
2
Insufficient Flow or Under Infusion
2
2
Protective Measures Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Wireless Communication Problem
2
2
Measurement System Incompatibility
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Loss of Data
2
2
Device Packaging Compromised
2
2
Device Sensing Problem
1
1
Electrical Shorting
1
1
Human Factors Issue
1
1
Improper Alarm
1
1
Inadequate User Interface
1
1
Infusion or Flow Problem
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Pressure Problem
1
1
Unexpected Shutdown
1
1
Missing Information
1
1
Key or Button Unresponsive/not Working
1
1
Insufficient Information
1
1
No Audible Prompt/Feedback
1
1
Failure to Deliver
1
1
Application Program Problem
1
1
Communication or Transmission Problem
1
1
Defective Device
1
1
Split
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Material Puncture/Hole
1
1
Material Separation
1
1
Failure to Read Input Signal
1
1
Smoking
1
1
Inaccurate Synchronization
1
1
Telemetry Discrepancy
1
1
Image Display Error/Artifact
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Break
1
1
Thermal Decomposition of Device
1
1
Burst Container or Vessel
1
1
Charred
1
1
Use of Incorrect Control/Treatment Settings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
42
42
No Clinical Signs, Symptoms or Conditions
40
40
No Consequences Or Impact To Patient
16
16
No Patient Involvement
12
12
Death
6
6
Insufficient Information
3
3
Injury
3
3
No Information
2
2
No Code Available
2
2
Overdose
2
2
Septic Shock
1
1
Cardiogenic Shock
1
1
Complaint, Ill-Defined
1
1
Hemorrhage/Bleeding
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Myocardial Infarction
1
1
Multiple Organ Failure
1
1
Drug Resistant Bacterial Infection
1
1
Low Oxygen Saturation
1
1
Missed Dose
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BARCO NV
II
Sep-29-2022
2
GE Healthcare, LLC
II
Jun-13-2022
3
GE Healthcare, LLC
II
Mar-16-2022
4
Philips Healthcare Inc.
II
Aug-31-2011
5
Philips Healthcare Inc.
II
Nov-18-2010
6
Philips Healthcare Inc.
II
Nov-24-2009
7
Philips Healthcare Inc.
II
Jul-07-2009
8
Philips Healthcare Inc.
II
May-27-2009
9
Spacelabs Healthcare, Incorporated
II
Nov-02-2010
10
Spacelabs Healthcare, Incorporated
II
Jan-19-2010
11
Spacelabs Healthcare, Llc
II
Dec-14-2010
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