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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, nuclear magnetic resonance imaging
Regulation Description Magnetic resonance diagnostic device.
Product CodeLNH
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ADAC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 4
ESAOTE
  SUBSTANTIALLY EQUIVALENT 19
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 101
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 54
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 16
MRI DEVICES CORP.
  SUBSTANTIALLY EQUIVALENT 10
ONI
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 78
SIEMENS
  SUBSTANTIALLY EQUIVALENT 102
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 20
USA INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Magnetic interference 39
No Known Device Problem 35
Normal 23
Use of Device Issue 8
Improper or incorrect procedure or method 8
No Information 7
Device operates differently than expected 6
Device Issue 4
Electrical issue 4
Connection issue 4
Device handling issue 3
Noise, Audible 3
Burn of device or device component 3
Disconnection 2
Heat 2
Instruction for use issue 2
Unintended magnet quench 2
Calibration issue 2
Device abrasion from instrument or another object 2
No code available 2
Unintended movement 2
Operating system becomes non-functional 1
Misassembled 1
Misconnection 1
Electro-magnetic interference (EMI), compatibility/incompatibility 1
No device output 1
User used incorrect product for intended use 1
Device remains implanted 1
Difficult to remove 1
Material rupture 1
Device stops intermittently 1
Malfunction 1
Sharp/jagged/rough/etched/scratched 1
Electrical shorting 1
Incompatibility problem 1
Naturally worn 1
Image reversal 1
Loose or intermittent connection 1
Magnet failure 1
Image display error 1
Mechanical issue 1
Artifact 1
Calibration error 1
Component incompatible 1
Entrapment of device or device component 1
Fire 1
Material frayed 1
Total Device Problems 189

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 2 0
Class II 7 7 3 8 10 10 11 6 9 6
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alltech Medical Systems America Inc I Feb-18-2015
2 Deerfield Imaging II Mar-11-2016
3 GE Healthcare II Nov-10-2015
4 GE Healthcare II Aug-05-2015
5 GE Healthcare II Mar-20-2015
6 GE Healthcare I Feb-18-2015
7 GE Healthcare II Sep-17-2008
8 GE Healthcare II Sep-16-2008
9 GE Healthcare II Sep-11-2008
10 GE Healthcare II Nov-07-2007
11 GE Healthcare, LLC II Jun-08-2016
12 GE Healthcare, LLC II May-01-2014
13 GE Healthcare, LLC II Apr-21-2014
14 GE Healthcare, LLC II Sep-27-2013
15 GE Healthcare, LLC II Sep-23-2013
16 GE Healthcare, LLC II Aug-09-2013
17 GE Healthcare, LLC II May-01-2013
18 GE Healthcare, LLC II May-01-2013
19 GE Healthcare, LLC II Apr-11-2013
20 GE Healthcare, LLC II Mar-11-2013
21 GE Healthcare, LLC II Feb-21-2012
22 GE Healthcare, LLC II Oct-26-2011
23 GE Healthcare, LLC II Sep-01-2011
24 GE Healthcare, LLC II Feb-24-2011
25 GE Healthcare, LLC II Feb-18-2011
26 GE Healthcare, LLC II Nov-24-2010
27 GE Healthcare, LLC II Nov-19-2010
28 GE Medical Systems LLC II May-18-2007
29 GE Medical Systems, LLC II Apr-07-2016
30 GE Medical Systems, LLC II Oct-30-2015
31 GE Medical Systems, LLC II Jan-11-2010
32 GE Medical Systems, LLC II Aug-25-2009
33 GE Medical Systems, LLC II Jun-30-2009
34 Hitachi Medical Systems America Inc II Sep-02-2014
35 Hitachi Medical Systems America Inc II Jun-19-2013
36 Hitachi Medical Systems America Inc II Aug-23-2012
37 Hitachi Medical Systems America Inc II Aug-23-2008
38 Hitachi Medical Systems America Inc II Sep-26-2007
39 Innovative Magnetic Resonance Imaging Systems Inc. II Nov-21-2012
40 MWT Materials, Inc. II Jan-21-2016
41 Odin Medical Technologies Ltd. II Aug-19-2010
42 Philips Electronics North America Corporation II Feb-26-2016
43 Philips Medical Systems (Cleveland) Inc II Oct-21-2013
44 Philips Medical Systems (Cleveland) Inc II Nov-28-2011
45 Philips Medical Systems (Cleveland) Inc II Feb-19-2010
46 Philips Medical Systems Nederlands II Feb-29-2012
47 Philips Medical Systems North America Co. Phillips II Mar-01-2011
48 Philips Medical Systems North America Co. Phillips II Dec-21-2010
49 Philips Medical Systems North America Co. Phillips II Nov-26-2010
50 Philips Medical Systems North America Co. Phillips II Sep-17-2010
51 Philips Medical Systems North America Co. Phillips II Jun-27-2007
52 Philips Medical Systems, Inc. II Nov-23-2015
53 Philips Medical Systems, Inc. II Oct-19-2015
54 Philips Medical Systems, Inc. II Mar-20-2015
55 Philips Medical Systems, Inc. II Jun-24-2014
56 Philips Medical Systems, Inc. II Jun-18-2014
57 Resonance Technology Inc II Sep-02-2008
58 Siemens Medical Solutions USA, Inc II May-03-2016
59 Siemens Medical Solutions USA, Inc II Dec-22-2015
60 Siemens Medical Solutions USA, Inc II Mar-20-2015
61 Siemens Medical Solutions USA, Inc II May-27-2014
62 Siemens Medical Solutions USA, Inc II Sep-26-2012
63 Siemens Medical Solutions USA, Inc II May-25-2012
64 Siemens Medical Solutions USA, Inc II Apr-02-2012
65 Siemens Medical Solutions USA, Inc II Feb-02-2012
66 Siemens Medical Solutions USA, Inc II Aug-10-2011
67 Siemens Medical Solutions USA, Inc II Jul-11-2011
68 Siemens Medical Solutions USA, Inc II Apr-18-2011
69 Siemens Medical Solutions USA, Inc II Feb-23-2011
70 Siemens Medical Solutions USA, Inc II Mar-25-2008
71 Siemens Medical Solutions USA, Inc II Feb-05-2008
72 Siemens Medical Solutions USA, Inc II Apr-26-2007
73 Toshiba American Medical Systems Inc II Nov-13-2013
74 Toshiba American Medical Systems Inc II Apr-11-2013
75 Toshiba American Medical Systems Inc II Sep-06-2012
76 Toshiba American Medical Systems Inc II Aug-28-2012
77 USA Instruments Incorporated II Feb-15-2007
78 USA Instruments Incorporated II Feb-15-2007
79 iCAD, Inc. II Jan-27-2009

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