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TPLC
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Device
device, digital image storage, radiological
Definition
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Product Code
LMB
Regulation Number
892.2010
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
21
21
2017
10
10
2018
5
5
2019
10
10
2020
8
8
2021
10
10
2023
10
10
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Display or Visual Feedback Problem
14
14
Computer Software Problem
12
12
No Display/Image
12
12
Data Problem
5
5
Patient Data Problem
4
4
Image Display Error/Artifact
4
4
No Device Output
3
3
Overheating of Device
3
3
Smoking
2
2
Defective Device
2
2
Communication or Transmission Problem
2
2
Poor Quality Image
2
2
Break
2
2
Device Operational Issue
2
2
Fire
2
2
Operating System Becomes Nonfunctional
1
1
Output below Specifications
1
1
Output Problem
1
1
Power Problem
1
1
Reset Problem
1
1
Missing Test Results
1
1
Noise, Audible
1
1
Unexpected Shutdown
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Application Program Problem: Dose Calculation Error
1
1
Loss of Data
1
1
Device Operates Differently Than Expected
1
1
Application Program Problem
1
1
Device Issue
1
1
Loss of Power
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
25
25
No Consequences Or Impact To Patient
6
6
Injury
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ge Healthcare It
II
Sep-06-2016
2
Merge Healthcare, Inc.
II
Apr-05-2017
3
Merge Healthcare, Inc.
II
Mar-29-2017
4
Merge Healthcare, Inc.
II
Mar-29-2017
5
Merge Healthcare, Inc.
II
Mar-10-2017
6
Merge Healthcare, Inc.
II
Aug-29-2016
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