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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, mobile
Regulation Description Mobile x-ray system.
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPT. OF THE ARMY
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 9
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
Minxray Inc
  SUBSTANTIALLY EQUIVALENT 11
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Device Issue 12
Malfunction 10
Unintended movement 6
Electrical shorting 5
Mechanical issue 4
Computer software issue 3
Use of Device Issue 3
Smoking 2
Device displays error message 2
Spark 2
Component falling 2
Break 2
Fire 2
Self-activation or keying 2
No Known Device Problem 2
Radiation Overexposure 2
Data Issue 2
Device handling issue 2
Device operates differently than expected 2
No Information 1
Slippage of device or device component 1
Image orientation incorrect 1
Device maintenance issue 1
Poor quality image 1
Device emits odor 1
Unintended collision 1
Unintended system motion 1
Overheating of device or device component 1
Device Difficult to Setup or Prepare 1
Burn of device or device component 1
Calibration error 1
Failure to charge 1
Collapse 1
Unintended arm motion 1
Disassembly 1
Electrical issue 1
Failure to fire 1
Battery issue 1
Detachment of device or device component 1
Device misassembled during manufacturing or shipping 1
Electronic property issue 1
Environmental control or utility issue 1
Human-Device Interface Issue 1
Material integrity issue 1
Sticking 1
Device stops intermittently 1
Device inoperable 1
Unknown (for use when the device problem is not known) 1
Low battery 1
Total Device Problems 97

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 3 0 1 3 2 12 10 9 6 3 4
Class III 0 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Jul-21-2014
2 AGFA Corp. II Jun-06-2013
3 AGFA Healthcare Corp. II Jun-10-2015
4 AGFA Healthcare Corp. III Aug-10-2014
5 AGFA Healthcare Corp. II Mar-29-2017
6 Carestream Health Inc II Jun-19-2017
7 Carestream Health Inc II Feb-03-2017
8 Carestream Health Inc II Dec-16-2014
9 Carestream Health Inc. II Jan-03-2014
10 Carestream Health Inc. II Nov-07-2013
11 Carestream Health Inc. II Nov-01-2013
12 Carestream Health, Inc. II Jan-21-2014
13 Carestream Health, Inc. II Oct-31-2013
14 Carestream Health, Inc. II Oct-31-2013
15 GE Healthcare II Apr-27-2015
16 GE Healthcare, LLC II Jan-11-2014
17 GE Healthcare, LLC II Aug-09-2013
18 GE Healthcare, LLC II Apr-10-2013
19 GE Healthcare, LLC II Nov-29-2012
20 GE Healthcare, LLC II Sep-13-2012
21 GE Healthcare, LLC II Jul-19-2012
22 GE Healthcare, LLC II Apr-24-2012
23 GE Medical Systems LLC II May-22-2007
24 GE Medical Systems, LLC II Feb-08-2016
25 GE OEC Medical Systems, Inc II Aug-01-2012
26 Medtronic Navigation, Inc II Feb-04-2009
27 Medtronic Navigation, Inc. II Jun-21-2012
28 Medtronic Navigation, Inc. II Nov-23-2010
29 Philips Healthcare Inc. II Apr-04-2017
30 Philips Healthcare Inc. II Aug-21-2013
31 Philips Healthcare Inc. II Jun-13-2012
32 Philips Healthcare Inc. II May-30-2012
33 Philips Medical Systems North America Co. Phillips II Mar-08-2011
34 Philips Medical Systems North America Co. Phillips II Sep-25-2007
35 Philips Medical Systems, Inc. II Dec-16-2014
36 Sedecal S.A. II Mar-08-2016
37 Sedecal S.A. II Aug-14-2015
38 Sedecal S.A. II Feb-02-2015
39 Sedecal USA, Inc. II Jun-03-2016
40 Shimadzu Medical Systems II Dec-18-2015
41 Shimadzu Medical Systems II Mar-07-2014
42 Shimadzu Medical Systems II Jun-03-2013
43 Shimadzu Medical Systems II Nov-08-2012
44 Siemens Medical Solutions USA, Inc II Jul-02-2014
45 Siemens Medical Solutions USA, Inc II Aug-05-2013
46 Siemens Medical Solutions USA, Inc II Dec-06-2012
47 Siemens Medical Solutions USA, Inc II Sep-11-2012
48 Siemens Medical Solutions USA, Inc II Sep-06-2012
49 Siemens Medical Solutions USA, Inc II Aug-11-2011
50 Siemens Medical Solutions USA, Inc II Dec-17-2010
51 Siemens Medical Solutions USA, Inc II Nov-01-2010
52 Siemens Medical Solutions USA, Inc II Apr-19-2007
53 Trans American Medical, Inc. II Jan-03-2014
54 Virtual Imaging, Inc. II Feb-09-2015

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