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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, angiographic
Regulation Description Angiographic x-ray system.
Product CodeIZI
Regulation Number 892.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 17
HEARTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
LEICA MICROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
SCHOLTEN SURGICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS
  SUBSTANTIALLY EQUIVALENT 15
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 4
VENUSA LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malfunction 10
Table top motion, unintended 7
Component falling 7
Device displays error message 5
Device operates differently than expected 5
Computer operating system issue 4
Radiation Overexposure 4
Electrical issue 4
Radiation overexposure 3
Device Issue 3
Detachment of device component 3
Unknown (for use when the device problem is not known) 3
Device inoperable 3
Loss of power 3
System fails to activate 3
No Known Device Problem 3
Power source issue 2
Self-activation or keying 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Device stops intermittently 2
Emergency stop button or switch failure 2
Emergency table stop failure 2
Bent 2
Unintended system motion 2
No device output 1
Difficult to position 1
Unintended arm motion 1
Computer failure 1
Computer software issue 1
Use of Incorrect Control Settings 1
Failure to deploy 1
Shock, electrical 1
Image display error 1
Image resolution poor 1
Loose or intermittent connection 1
Loose 1
Migration of device or device component 1
Mislocation 1
Monitor failure 1
Poor quality image 1
Defective component 1
Failure to fire 1
Smoking 1
Source, detachment from 1
Human-Device Interface Issue 1
Temperature issue 1
Unintended movement 1
No Information 1
No code available 1
Data Issue 1
Total Device Problems 114

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 4 6 5 8 4 8 7 10 7 6
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Jul-03-2015
2 GE Healthcare II Sep-16-2008
3 GE Healthcare, LLC II Dec-16-2014
4 GE Healthcare, LLC II Jan-28-2014
5 GE Healthcare, LLC II Oct-17-2012
6 GE Healthcare, LLC II Mar-19-2012
7 GE Medical Systems, LLC II Dec-12-2015
8 GE Medical Systems, LLC II Nov-09-2009
9 NeuroLogica Corporation II Nov-10-2015
10 Novadaq Technologies, Inc. III Dec-01-2014
11 Philips Electronics North America Corporation II Feb-16-2016
12 Philips Electronics North America Corporation II Jan-30-2016
13 Philips Healthcare Inc. II Jun-20-2012
14 Philips Healthcare Inc. II Apr-25-2012
15 Philips Healthcare Inc. II Mar-29-2012
16 Philips Healthcare Inc. II Feb-08-2012
17 Philips Healthcare Inc. II Feb-02-2012
18 Philips Healthcare Inc. II Aug-10-2011
19 Philips Medical Systems Nederlands II Mar-09-2012
20 Philips Medical Systems North America Co. Phillips II Mar-22-2011
21 Philips Medical Systems North America Co. Phillips II Mar-16-2011
22 Philips Medical Systems North America Co. Phillips II Jan-18-2011
23 Philips Medical Systems North America Co. Phillips II Dec-07-2010
24 Philips Medical Systems North America Co. Phillips II Oct-22-2010
25 Philips Medical Systems North America Co. Phillips II Sep-22-2010
26 Philips Medical Systems North America Co. Phillips II Sep-22-2010
27 Philips Medical Systems North America Co. Phillips II Aug-11-2010
28 Philips Medical Systems North America Co. Phillips II Sep-24-2009
29 Philips Medical Systems North America Co. Phillips II Sep-16-2008
30 Philips Medical Systems North America Co. Phillips II Dec-07-2007
31 Philips Medical Systems North America Co. Phillips II Sep-25-2007
32 Philips Medical Systems North America Co. Phillips II Jan-25-2007
33 Philips Medical Systems, Inc. II Mar-31-2016
34 Philips Medical Systems, Inc. II Mar-02-2015
35 Philips Medical Systems, Inc. II Feb-26-2015
36 Shimadzu Medical Systems II May-08-2014
37 Siemens Medical Solutions USA, Inc II Mar-31-2016
38 Siemens Medical Solutions USA, Inc II Mar-31-2016
39 Siemens Medical Solutions USA, Inc II Mar-31-2016
40 Siemens Medical Solutions USA, Inc II Aug-05-2015
41 Siemens Medical Solutions USA, Inc II Jan-14-2015
42 Siemens Medical Solutions USA, Inc II Dec-01-2014
43 Siemens Medical Solutions USA, Inc II Nov-07-2014
44 Siemens Medical Solutions USA, Inc II Sep-24-2014
45 Siemens Medical Solutions USA, Inc II Sep-22-2014
46 Siemens Medical Solutions USA, Inc II Mar-31-2014
47 Siemens Medical Solutions USA, Inc II Mar-22-2014
48 Siemens Medical Solutions USA, Inc II Feb-24-2014
49 Siemens Medical Solutions USA, Inc II Nov-14-2013
50 Siemens Medical Solutions USA, Inc II Aug-28-2013
51 Siemens Medical Solutions USA, Inc II Aug-09-2013
52 Siemens Medical Solutions USA, Inc II Jul-22-2013
53 Siemens Medical Solutions USA, Inc II Jul-17-2013
54 Siemens Medical Solutions USA, Inc II Mar-26-2013
55 Siemens Medical Solutions USA, Inc II Mar-25-2013
56 Siemens Medical Solutions USA, Inc II Oct-26-2010
57 Siemens Medical Solutions USA, Inc II Aug-16-2010
58 Siemens Medical Solutions USA, Inc II Apr-08-2010
59 Siemens Medical Solutions USA, Inc II Dec-03-2009
60 Siemens Medical Solutions USA, Inc II Nov-10-2009
61 Siemens Medical Solutions USA, Inc II Jun-16-2009
62 Siemens Medical Solutions USA, Inc II Dec-09-2008
63 Siemens Medical Solutions USA, Inc II Nov-25-2008
64 Siemens Medical Solutions USA, Inc II Nov-04-2008
65 Siemens Medical Solutions USA, Inc II Nov-04-2008
66 Siemens Medical Solutions USA, Inc II Mar-08-2007

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