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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

Device Problems
Computer Software Problem 10
Image Display Error/Artifact 4
Data Problem 4
No Display/Image 4
Patient Data Problem 4
Device Operational Issue 2
Defective Device 2
Unexpected Shutdown 1
Application Program Problem 1
Missing Test Results 1
Device Issue 1
Communication or Transmission Problem 1
Overheating of Device 1
Fire 1
Total Device Problems 37

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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