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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
DEPT. OF THE ARMY
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 7
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
Minxray Inc
  SUBSTANTIALLY EQUIVALENT 8
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Device Issue 10
Malfunction 10
Device operates differently than expected 2
Device displays error message 1
Spark 1
Failure to fire 1
Calibration error 1
Component falling 1
Electrical issue 1
Fire 1
Image orientation incorrect 1
Mechanical issue 1
Poor quality image 1
Device emits odor 1
Smoking 1
Sticking 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 36

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 3 0 1 3 2 12 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Apr-10-2013
2 GE Healthcare, LLC II Nov-29-2012
3 GE Healthcare, LLC II Sep-13-2012
4 GE Healthcare, LLC II Jul-19-2012
5 GE Healthcare, LLC II Apr-24-2012
6 GE Medical Systems LLC II May-22-2007
7 GE OEC Medical Systems, Inc II Aug-01-2012
8 Medtronic Navigation, Inc II Feb-04-2009
9 Medtronic Navigation, Inc. II Jun-21-2012
10 Medtronic Navigation, Inc. II Nov-23-2010
11 Philips Healthcare Inc. II Jun-13-2012
12 Philips Healthcare Inc. II May-30-2012
13 Philips Medical Systems North America Co. Phillips II Mar-08-2011
14 Philips Medical Systems North America Co. Phillips II Sep-25-2007
15 Shimadzu Medical Systems II Nov-08-2012
16 Siemens Medical Solutions USA, Inc II Dec-06-2012
17 Siemens Medical Solutions USA, Inc II Sep-11-2012
18 Siemens Medical Solutions USA, Inc II Sep-06-2012
19 Siemens Medical Solutions USA, Inc II Aug-11-2011
20 Siemens Medical Solutions USA, Inc II Dec-17-2010
21 Siemens Medical Solutions USA, Inc II Nov-01-2010
22 Siemens Medical Solutions USA, Inc II Apr-19-2007

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