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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device device, digital image storage, radiological
Regulation Description Medical image storage device.
Product CodeLMB
Regulation Number 892.2010
Device Class 1


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 4
FUJI
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 3
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Computer software issue 9
Data Issue 4
Patient Data Issue 4
Failure to back-up 1
No display or display failure 1
Device Issue 1
Application program issue 1
Total Device Problems 21

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 4 1 2 0 0 1 0 2
Class III 0 0 0 0 0 0 0 0 0 0

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 Aug-29-2016
5 Siemens Medical Solutions USA, Inc II Aug-10-2011
6 Siemens Medical Solutions USA, Inc II May-06-2011
7 Stryker Endoscopy II May-10-2010
8 Stryker Endoscopy II Sep-11-2008
9 Stryker Imaging II Nov-10-2009
10 Stryker Imaging II Nov-10-2009
11 Stryker Imaging II Nov-09-2009

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