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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, digital image storage, radiological
Regulation Description Medical image storage device.
Definition Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Product CodeLMB
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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 11 11
No Display/Image 8 8
Data Problem 5 5
Image Display Error/Artifact 4 4
Patient Data Problem 4 4
No Device Output 3 3
Overheating of Device 2 2
Fire 2 2
Device Operational Issue 2 2
Defective Device 2 2
Application Program Problem 1 1
Communication or Transmission Problem 1 1
Device Operates Differently Than Expected 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Missing Test Results 1 1
Unexpected Shutdown 1 1
Break 1 1
Display or Visual Feedback Problem 1 1
Loss of Power 1 1
Smoking 1 1
Device Issue 1 1
Loss of Data 1 1
Reset Problem 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Application Program Problem: Dose Calculation Error 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
VDT (Video Display Terminal) 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 42 42
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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