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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 14
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 95
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 50
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 16
MRI DEVICES CORP.
  SUBSTANTIALLY EQUIVALENT 10
ONI
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 78
SIEMENS
  SUBSTANTIALLY EQUIVALENT 89
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 16
USA INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VARIAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Magnetic interference 39
Normal 23
No Known Device Problem 11
Device operates differently than expected 2
Unintended magnet quench 2
Heat 2
Device abrasion from instrument or another object 2
Use of Device Issue 1
No Information 1
Artifact 1
Operating system becomes non-functional 1
Image reversal 1
Magnet failure 1
Device remains implanted 1
Electro-magnetic interference (EMI), compatibility/incompatibility 1
Device Issue 1
Burn of device or device component 1
Entrapment of device or device component 1
Material frayed 1
Material rupture 1
Malfunction 1
Sharp/jagged/rough/etched/scratched 1
Image display error 1
Total Device Problems 97

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 7 7 3 8 10 12 5
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Sep-17-2008
2 GE Healthcare II Sep-16-2008
3 GE Healthcare II Sep-11-2008
4 GE Healthcare II Nov-07-2007
5 GE Healthcare, LLC II May-01-2013
6 GE Healthcare, LLC II May-01-2013
7 GE Healthcare, LLC II Apr-11-2013
8 GE Healthcare, LLC II Mar-11-2013
9 GE Healthcare, LLC II Feb-21-2012
10 GE Healthcare, LLC II Oct-26-2011
11 GE Healthcare, LLC II Sep-01-2011
12 GE Healthcare, LLC II Feb-24-2011
13 GE Healthcare, LLC II Feb-18-2011
14 GE Healthcare, LLC II Nov-24-2010
15 GE Healthcare, LLC II Nov-19-2010
16 GE Medical Systems LLC II May-18-2007
17 GE Medical Systems, LLC II Jan-11-2010
18 GE Medical Systems, LLC II Aug-25-2009
19 GE Medical Systems, LLC II Jun-30-2009
20 Hitachi Medical Systems America Inc II Aug-23-2012
21 Hitachi Medical Systems America Inc II Aug-23-2008
22 Hitachi Medical Systems America Inc II Sep-26-2007
23 Innovative Magnetic Resonance Imaging Systems Inc. II Nov-21-2012
24 Odin Medical Technologies Ltd. II Aug-19-2010
25 Philips Medical Systems (Cleveland) Inc II Nov-28-2011
26 Philips Medical Systems (Cleveland) Inc II Feb-19-2010
27 Philips Medical Systems (Cleveland), Inc. II Nov-05-2012
28 Philips Medical Systems (Cleveland), Inc. II Jan-11-2012
29 Philips Medical Systems Nederlands II Feb-29-2012
30 Philips Medical Systems North America Co. Phillips II Mar-01-2011
31 Philips Medical Systems North America Co. Phillips II Dec-21-2010
32 Philips Medical Systems North America Co. Phillips II Nov-26-2010
33 Philips Medical Systems North America Co. Phillips II Sep-17-2010
34 Philips Medical Systems North America Co. Phillips II Jun-27-2007
35 Resonance Technology Inc II Sep-02-2008
36 Siemens Medical Solutions USA, Inc II Sep-26-2012
37 Siemens Medical Solutions USA, Inc II May-25-2012
38 Siemens Medical Solutions USA, Inc II Apr-02-2012
39 Siemens Medical Solutions USA, Inc II Feb-02-2012
40 Siemens Medical Solutions USA, Inc II Aug-10-2011
41 Siemens Medical Solutions USA, Inc II Jul-11-2011
42 Siemens Medical Solutions USA, Inc II Apr-18-2011
43 Siemens Medical Solutions USA, Inc II Feb-23-2011
44 Siemens Medical Solutions USA, Inc II Mar-25-2008
45 Siemens Medical Solutions USA, Inc II Feb-05-2008
46 Siemens Medical Solutions USA, Inc II Apr-26-2007
47 Toshiba American Medical Systems Inc II Apr-11-2013
48 Toshiba American Medical Systems Inc II Sep-06-2012
49 Toshiba American Medical Systems Inc II Aug-28-2012
50 USA Instruments Incorporated II Feb-15-2007
51 USA Instruments Incorporated II Feb-15-2007
52 iCAD, Inc. II Jan-27-2009

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