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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, stationary
Regulation Description Stationary x-ray system.
Product CodeKPR
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 3
FUJI
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 13
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.C. JOHNSON CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 4
VARIAN
  SUBSTANTIALLY EQUIVALENT 1
WU'S
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Defective component 29
Invalid sensing 12
Normal 8
Unintended system motion 5
Use of Device Issue 4
Improper or incorrect procedure or method 4
Device inoperable 3
Component falling 3
Tears, rips, holes in device, device material 2
Bent 2
Malfunction 2
Unknown (for use when the device problem is not known) 2
Component missing 1
Device Issue 1
Detachment of device component 1
Material separation 1
Slippage of device or device component 1
Total Device Problems 81

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 4 8 5 6 1 8 1
Class III 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Carestream Health, Inc. II Feb-23-2008
2 Carestream Health, Inc. II Jul-03-2007
3 Carestream Health, Inc. II Jun-30-2007
4 GE Healthcare II Sep-30-2008
5 GE Healthcare II Sep-25-2008
6 GE Healthcare II Sep-25-2008
7 GE Healthcare II Sep-25-2008
8 GE Healthcare II Sep-04-2008
9 GE Healthcare II Jun-10-2008
10 GE Healthcare, LLC II Feb-21-2012
11 GE Healthcare, LLC II Jan-11-2012
12 GE Healthcare, LLC II Sep-25-2009
13 GE Medical Systems, LLC II Dec-16-2009
14 GE Medical Systems, LLC II Sep-24-2009
15 GE Medical Systems, LLC II Sep-22-2009
16 General Electric Med Systems LLC II Jun-08-2012
17 General Electric Med Systems LLC II Sep-25-2007
18 Philips Healthcare Inc. II Feb-01-2013
19 Philips Healthcare Inc. II Aug-15-2012
20 Philips Healthcare Inc. II Aug-08-2012
21 Philips Healthcare Inc. II Mar-27-2012
22 Philips Healthcare Inc. II Mar-15-2012
23 Philips Healthcare Inc. II Jan-11-2012
24 Philips Medical Systems North America Co. Phillips II Nov-26-2010
25 Philips Medical Systems North America Co. Phillips II Oct-07-2010
26 Philips Medical Systems North America Co. Phillips II Oct-06-2010
27 Philips Medical Systems North America Co. Phillips II Sep-14-2010
28 Philips Medical Systems North America Co. Phillips II Aug-10-2010
29 Philips Medical Systems North America Co. Phillips II Mar-23-2010
30 Philips Medical Systems North America Co. Phillips II Sep-25-2009
31 Philips Medical Systems North America Co. Phillips III Sep-16-2008
32 Philips Medical Systems North America Co. Phillips II Sep-25-2007
33 Siemens Medical Solutions USA, Inc II Apr-12-2011
34 Siemens Medical Solutions USA, Inc II Oct-20-2008

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