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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 20
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 103
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 21
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 9
Improper or incorrect procedure or method 8
No Information 7
Device operates differently than expected 6
No code available 4
Device Issue 4
Connection issue 4
Electrical issue 4
Burn of device or device component 3
Device handling issue 3
Noise, Audible 3
Electrical shorting 2
Unintended movement 2
Disconnection 2
Heat 2
Instruction for use issue 2
Calibration issue 2
Unintended magnet quench 2
Device stops intermittently 2
Device abrasion from instrument or another object 2
Misassembled 1
Misconnection 1
Mechanical issue 1
No device output 1
User used incorrect product for intended use 1
Device remains implanted 1
Difficult to remove 1
Material rupture 1
Electro-magnetic interference (EMI), compatibility/incompatibility 1
Malfunction 1
Sharp/jagged/rough/etched/scratched 1
Image reversal 1
Loose or intermittent connection 1
Magnet failure 1
Image display error 1
Artifact 1
Calibration error 1
Component incompatible 1
Computer software issue 1
Application interface becomes non-functional or program exits abnormally 1
Entrapment of device or device component 1
Fire 1
Material frayed 1
Not Applicable 1
Operating system becomes non-functional 1
Incompatibility problem 1
Naturally worn 1
Total Device Problems 197

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

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