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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 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 15
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 9
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 1
WU'S
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Defective component 29
Invalid sensing 12
Normal 8
Improper or incorrect procedure or method 8
Unintended system motion 7
Use of Device Issue 6
Component falling 6
Device inoperable 3
Unknown (for use when the device problem is not known) 2
Detachment of device component 2
Tears, rips, holes in device, device material 2
Bent 2
Malfunction 2
No code available 2
Device handling issue 2
Data Issue 1
Device operates differently than expected 1
Dislodged or dislocated 1
Incorrect device or component shipped 1
No Known Device Problem 1
Unintended movement 1
No Information 1
Component missing 1
Device Issue 1
Break 1
Unintended collision 1
Electrical issue 1
Fire 1
Mechanical issue 1
Material separation 1
Slippage of device or device component 1
Total Device Problems 109

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 4 8 5 6 1 7 6 11 9 5 2
Class III 0 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Aug-10-2014
2 AGFA Healthcare Corp. II Apr-05-2017
3 Carestream Health Inc II Aug-22-2015
4 Carestream Health Inc. II Aug-01-2014
5 Carestream Health Inc. II Jan-29-2014
6 Carestream Health Inc. II Aug-12-2013
7 Carestream Health, Inc. II Aug-10-2014
8 Carestream Health, Inc. II Jan-27-2014
9 Carestream Health, Inc. II Feb-23-2008
10 Carestream Health, Inc. II Jul-03-2007
11 Carestream Health, Inc. II Jun-30-2007
12 GE Healthcare II Mar-06-2015
13 GE Healthcare II Jan-12-2015
14 GE Healthcare II Sep-30-2008
15 GE Healthcare II Sep-25-2008
16 GE Healthcare II Sep-25-2008
17 GE Healthcare II Sep-25-2008
18 GE Healthcare II Sep-04-2008
19 GE Healthcare II Jun-10-2008
20 GE Healthcare, LLC II Jul-02-2014
21 GE Healthcare, LLC II Feb-21-2012
22 GE Healthcare, LLC II Jan-11-2012
23 GE Healthcare, LLC II Sep-25-2009
24 GE Medical Systems, LLC II Dec-16-2009
25 GE Medical Systems, LLC II Sep-24-2009
26 GE Medical Systems, LLC II Sep-22-2009
27 General Electric Med Systems LLC II Jun-08-2012
28 General Electric Med Systems LLC II Sep-25-2007
29 Philips Electronics North America Corporation II Sep-01-2016
30 Philips Electronics North America Corporation II Feb-05-2016
31 Philips Healthcare II Jun-03-2016
32 Philips Healthcare Inc. II Aug-26-2013
33 Philips Healthcare Inc. II Jun-17-2013
34 Philips Healthcare Inc. II Feb-01-2013
35 Philips Healthcare Inc. II Aug-15-2012
36 Philips Healthcare Inc. II Aug-08-2012
37 Philips Healthcare Inc. II Mar-27-2012
38 Philips Healthcare Inc. II Mar-15-2012
39 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
40 Philips Medical Systems North America Co. Phillips II Nov-26-2010
41 Philips Medical Systems North America Co. Phillips II Oct-07-2010
42 Philips Medical Systems North America Co. Phillips II Oct-06-2010
43 Philips Medical Systems North America Co. Phillips II Sep-14-2010
44 Philips Medical Systems North America Co. Phillips II Aug-10-2010
45 Philips Medical Systems North America Co. Phillips II Mar-23-2010
46 Philips Medical Systems North America Co. Phillips II Sep-25-2009
47 Philips Medical Systems North America Co. Phillips III Sep-16-2008
48 Philips Medical Systems North America Co. Phillips II Sep-25-2007
49 Philips Medical Systems, Inc. II Mar-31-2016
50 Philips Medical Systems, Inc. II Dec-03-2015
51 Philips Medical Systems, Inc. II May-19-2015
52 Philips Medical Systems, Inc. II Mar-06-2015
53 Philips Medical Systems, Inc. II Dec-02-2013
54 Siemens Medical Solutions USA, Inc II Oct-04-2016
55 Siemens Medical Solutions USA, Inc II May-23-2015
56 Siemens Medical Solutions USA, Inc II May-05-2015
57 Siemens Medical Solutions USA, Inc II Jan-16-2015
58 Siemens Medical Solutions USA, Inc II Oct-02-2014
59 Siemens Medical Solutions USA, Inc II Sep-23-2014
60 Siemens Medical Solutions USA, Inc II Jun-21-2014
61 Siemens Medical Solutions USA, Inc II Jun-04-2014
62 Siemens Medical Solutions USA, Inc II Apr-24-2014
63 Siemens Medical Solutions USA, Inc II Nov-26-2013
64 Siemens Medical Solutions USA, Inc II Apr-12-2011
65 Siemens Medical Solutions USA, Inc II Oct-20-2008

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