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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, patient position, light-beam
Product CodeIWE
Regulation Number 892.5780
Device Class 1


Premarket Reviews
ManufacturerDecision
GAMMEX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1
Device Displays Incorrect Message 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II May-01-2015
2 GE Healthcare, LLC II Feb-08-2012
3 GE Healthcare, LLC II Jul-21-2011
4 Hitachi Medical Systems America Inc II May-04-2010
5 Omega Medical Imaging, Inc. II Oct-24-2023
6 Omega Medical Imaging, Inc. II Oct-24-2023
7 Omega Medical Imaging, Inc. II Jun-19-2017
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