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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
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
2014 1 1
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 4 4
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
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare Integrated IT Solutions II Sep-24-2009
2 Ge Healthcare It II Sep-06-2016
3 Ge Healthcare It II Dec-19-2014
4 Merge Healthcare, Inc. II Apr-05-2017
5 Merge Healthcare, Inc. II Mar-29-2017
6 Merge Healthcare, Inc. II Mar-29-2017
7 Merge Healthcare, Inc. II Mar-10-2017
8 Merge Healthcare, Inc. II Aug-29-2016
9 Siemens Medical Solutions USA, Inc II Aug-10-2011
10 Siemens Medical Solutions USA, Inc II May-06-2011
11 Stryker Endoscopy II May-10-2010
12 Stryker Imaging II Nov-10-2009
13 Stryker Imaging II Nov-10-2009
14 Stryker Imaging II Nov-09-2009
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