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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device solid state x-ray imager (flat panel/digital imager)
Regulation Description Stationary x-ray system.
Product CodeMQB
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA COMPANY
  SUBSTANTIALLY EQUIVALENT 4
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CANON
  SUBSTANTIALLY EQUIVALENT 6
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 4
FUJI
  SUBSTANTIALLY EQUIVALENT 10
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
LIEBEL-FLARSHIEM CO.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 5
VARIAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Image display error 192
Device displays error message 63
Loss of Data 19
Migration of device or device component 15
Operating system becomes non-functional 9
Computer software issue 6
Device operates differently than expected 4
Application interface becomes non-functional or program exits abnormally 3
Device inoperable 2
Overheating of device or device component 2
Incorrect or inadequate result 1
Lens (IOL), migration of intraocular 1
Component falling 1
Poor quality image 1
Failure to power-up 1
Computer operating system issue 1
Image resolution poor 1
Incorrect software programming calculations 1
Dose calculation error due to software problem 1
No code available 1
Total Device Problems 325

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 6 9 11 14 6 17 11 3 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Mar-19-2013
2 AGFA Corp. II Feb-19-2012
3 AGFA Corp. II Jan-11-2012
4 AGFA Corp. II May-04-2011
5 AGFA Corp. II Nov-26-2010
6 AGFA Corp. II Jul-26-2010
7 Canon Inc. II Aug-24-2012
8 Carestream Health Inc. II Nov-07-2013
9 Carestream Health, Inc. II Aug-13-2012
10 Cooper Surgical, Inc. II Apr-03-2013
11 Datex - Ohmeda, Inc II Sep-30-2008
12 Datex - Ohmeda, Inc II Sep-30-2008
13 EOS Imaging II Jan-09-2014
14 Eos Imaging Inc II May-05-2015
15 Eos Imaging Inc II Sep-28-2012
16 GE Healthcare II Sep-29-2008
17 GE Healthcare II Sep-21-2008
18 GE Healthcare II Sep-20-2008
19 GE Healthcare II Sep-16-2008
20 GE Healthcare II Jan-31-2008
21 GE Healthcare II Sep-28-2007
22 GE Healthcare, LLC II Feb-24-2014
23 GE Healthcare, LLC II Mar-13-2013
24 GE Healthcare, LLC II Mar-11-2013
25 GE Healthcare, LLC II Sep-13-2012
26 GE Healthcare, LLC II Oct-28-2011
27 GE Healthcare, LLC II Nov-17-2010
28 GE Healthcare, LLC II Nov-16-2010
29 GE Healthcare, LLC II Aug-19-2010
30 GE Medical Systems, LLC II Jan-13-2010
31 GE Medical Systems, LLC II Dec-16-2009
32 GE Medical Systems, LLC II Nov-09-2009
33 GE Medical Systems, LLC II Sep-24-2009
34 GE Medical Systems, LLC II Sep-24-2009
35 GE Medical Systems, LLC II Jun-19-2009
36 GE Medical Systems, LLC II May-19-2009
37 GE Medical Systems, LLC II Mar-12-2009
38 GE Medical Systems, LLC II Jan-21-2009
39 Ge Healthcare II Sep-24-2009
40 Ge Healthcare, Llc II Jun-29-2010
41 Ge Healthcare, Llc II May-26-2010
42 General Electric Med Systems LLC II Jun-08-2012
43 General Electric Med Systems LLC II Jul-10-2007
44 General Electric Med Systems LLC II Jun-09-2007
45 General Electric Med Systems LLC II Jun-05-2007
46 Philips Electronics North America Corporation II Nov-11-2015
47 Philips Healthcare Inc. II Jun-17-2013
48 Philips Healthcare Inc. II Mar-01-2013
49 Philips Healthcare Inc. II Feb-26-2013
50 Philips Healthcare Inc. II Dec-05-2012
51 Philips Healthcare Inc. II Sep-28-2012
52 Philips Healthcare Inc. II Sep-27-2012
53 Philips Healthcare Inc. II Sep-14-2012
54 Philips Healthcare Inc. II Jun-15-2012
55 Philips Healthcare Inc. II Apr-26-2012
56 Philips Healthcare Inc. II Nov-30-2011
57 Philips Medical Systems North America Co. Phillips II Mar-23-2010
58 Philips Medical Systems North America Co. Phillips II Sep-25-2007
59 Philips Medical Systems, Inc. II May-19-2015
60 Philips Medical Systems, Inc. II Dec-27-2013
61 Siemens Medical Solutions USA, Inc II Jul-24-2013
62 Siemens Medical Solutions USA, Inc II Apr-09-2012
63 Siemens Medical Solutions USA, Inc II Mar-05-2012
64 Siemens Medical Solutions USA, Inc II Jan-25-2012
65 Siemens Medical Solutions USA, Inc II Jul-11-2011
66 Siemens Medical Solutions USA, Inc II Feb-23-2011
67 Siemens Medical Solutions USA, Inc II Dec-17-2010
68 Siemens Medical Solutions USA, Inc II Aug-13-2010
69 Siemens Medical Solutions USA, Inc II May-28-2010
70 Siemens Medical Solutions USA, Inc II Apr-05-2010
71 Siemens Medical Solutions USA, Inc II May-06-2009
72 Siemens Medical Solutions USA, Inc II Nov-28-2008
73 Siemens Medical Solutions USA, Inc II Oct-10-2008
74 Toshiba American Med Sys Inc II Nov-27-2007
75 Toshiba American Medical Systems Inc II Jun-04-2014
76 Toshiba American Medical Systems Inc II Mar-25-2013
77 Toshiba American Medical Systems Inc II Feb-02-2012
78 Toshiba American Medical Systems Inc II Dec-01-2011
79 Toshiba American Medical Systems Inc II Mar-22-2010
80 Toshiba American Medical Systems Inc II Sep-28-2009

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