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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 21
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 107
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 108
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 24
USA INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 53
Magnetic interference 39
Normal 24
Use of Device Issue 21
Improper or incorrect procedure or method 13
No Information 13
Device operates differently than expected 9
Device Issue 8
Electrical issue 5
Connection issue 5
No code available 4
Device handling issue 4
Burn of device or device component 4
Device stops intermittently 3
Noise, Audible 3
Unintended magnet quench 3
Unintended movement 2
Not Applicable 2
Electrical shorting 2
Arcing 2
Device displays error message 2
Calibration issue 2
Communication or transmission issue 2
Mechanical issue 2
Device abrasion from instrument or another object 2
Overheating of device or device component 2
Disconnection 2
Heat 2
Instruction for use issue 2
Loose or intermittent connection 2
Magnet failure 1
Image reversal 1
Image display error 1
Image orientation incorrect 1
Artifact 1
Calibration error 1
Circuit Failure 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
User used incorrect product for intended use 1
Device remains implanted 1
Difficult to remove 1
Material rupture 1
Misassembled 1
Misconnection 1
Device inoperable 1
No device output 1
Malfunction 1
Electro-magnetic interference (EMI), compatibility/incompatibility 1
Sharp/jagged/rough/etched/scratched 1
Incompatibility problem 1
Naturally worn 1
Operating system becomes non-functional 1
Positioning Issue 1
Temperature issue 1
Total Device Problems 268

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 2 0 0
Class II 7 7 3 8 10 10 11 6 9 12 5
Class III 0 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 Feb-10-2017
13 GE Healthcare, LLC II Sep-02-2016
14 GE Healthcare, LLC II Jul-06-2016
15 GE Healthcare, LLC II Jun-08-2016
16 GE Healthcare, LLC II May-01-2014
17 GE Healthcare, LLC II Apr-21-2014
18 GE Healthcare, LLC II Sep-27-2013
19 GE Healthcare, LLC II Sep-23-2013
20 GE Healthcare, LLC II Aug-09-2013
21 GE Healthcare, LLC II May-01-2013
22 GE Healthcare, LLC II May-01-2013
23 GE Healthcare, LLC II Apr-11-2013
24 GE Healthcare, LLC II Mar-11-2013
25 GE Healthcare, LLC II Feb-21-2012
26 GE Healthcare, LLC II Oct-26-2011
27 GE Healthcare, LLC II Sep-01-2011
28 GE Healthcare, LLC II Feb-24-2011
29 GE Healthcare, LLC II Feb-18-2011
30 GE Healthcare, LLC II Nov-24-2010
31 GE Healthcare, LLC II Nov-19-2010
32 GE Medical Systems LLC II May-18-2007
33 GE Medical Systems, LLC II Aug-02-2017
34 GE Medical Systems, LLC II Apr-07-2016
35 GE Medical Systems, LLC II Oct-30-2015
36 GE Medical Systems, LLC II Jan-11-2010
37 GE Medical Systems, LLC II Aug-25-2009
38 GE Medical Systems, LLC II Jun-30-2009
39 Hitachi Medical Systems America Inc II Mar-23-2017
40 Hitachi Medical Systems America Inc II Jan-26-2017
41 Hitachi Medical Systems America Inc II Sep-02-2014
42 Hitachi Medical Systems America Inc II Jun-19-2013
43 Hitachi Medical Systems America Inc II Aug-23-2012
44 Hitachi Medical Systems America Inc II Aug-23-2008
45 Hitachi Medical Systems America Inc II Sep-26-2007
46 Innovative Magnetic Resonance Imaging Systems Inc. II Nov-21-2012
47 MWT Materials, Inc. II Jan-21-2016
48 Medtronic Navigation II Jul-06-2016
49 Odin Medical Technologies Ltd. II Aug-19-2010
50 Philips Electronics North America Corporation II Dec-19-2016
51 Philips Electronics North America Corporation II Feb-26-2016
52 Philips Medical Systems (Cleveland) Inc II Oct-21-2013
53 Philips Medical Systems (Cleveland) Inc II Nov-28-2011
54 Philips Medical Systems (Cleveland) Inc II Feb-19-2010
55 Philips Medical Systems Nederlands II Feb-29-2012
56 Philips Medical Systems North America Co. Phillips II Mar-01-2011
57 Philips Medical Systems North America Co. Phillips II Dec-21-2010
58 Philips Medical Systems North America Co. Phillips II Nov-26-2010
59 Philips Medical Systems North America Co. Phillips II Sep-17-2010
60 Philips Medical Systems North America Co. Phillips II Jun-27-2007
61 Philips Medical Systems, Inc. II Nov-23-2015
62 Philips Medical Systems, Inc. II Oct-19-2015
63 Philips Medical Systems, Inc. II Mar-20-2015
64 Philips Medical Systems, Inc. II Jun-24-2014
65 Philips Medical Systems, Inc. II Jun-18-2014
66 Resonance Technology Inc II Sep-02-2008
67 Siemens Medical Solutions USA, Inc II Apr-10-2017
68 Siemens Medical Solutions USA, Inc II May-03-2016
69 Siemens Medical Solutions USA, Inc II Dec-22-2015
70 Siemens Medical Solutions USA, Inc II Mar-20-2015
71 Siemens Medical Solutions USA, Inc II May-27-2014
72 Siemens Medical Solutions USA, Inc II Sep-26-2012
73 Siemens Medical Solutions USA, Inc II May-25-2012
74 Siemens Medical Solutions USA, Inc II Apr-02-2012
75 Siemens Medical Solutions USA, Inc II Feb-02-2012
76 Siemens Medical Solutions USA, Inc II Aug-10-2011
77 Siemens Medical Solutions USA, Inc II Jul-11-2011
78 Siemens Medical Solutions USA, Inc II Apr-18-2011
79 Siemens Medical Solutions USA, Inc II Feb-23-2011
80 Siemens Medical Solutions USA, Inc II Mar-25-2008
81 Siemens Medical Solutions USA, Inc II Feb-05-2008
82 Siemens Medical Solutions USA, Inc II Apr-26-2007
83 Toshiba American Medical Systems Inc II Jul-06-2016
84 Toshiba American Medical Systems Inc II Nov-13-2013
85 Toshiba American Medical Systems Inc II Apr-11-2013
86 Toshiba American Medical Systems Inc II Sep-06-2012
87 Toshiba American Medical Systems Inc II Aug-28-2012
88 USA Instruments Incorporated II Feb-15-2007
89 USA Instruments Incorporated II Feb-15-2007
90 iCAD, Inc. II Jan-27-2009

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