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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device system, tomography, computed, emission
Regulation Description Emission computed tomography system.
Product CodeKPS
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
BRACCO
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CEDARS-SINAI MEDICAL CENTER
  SUBSTANTIALLY EQUIVALENT 2
DDD-DIAGNOSTIC A/S
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 6
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 6
HERMES MEDICAL SOLUTIONS, AB
  SUBSTANTIALLY EQUIVALENT 3
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 12
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 8
Use of Device Problem 8
Improper or Incorrect Procedure or Method 5
Mechanical Problem 5
Positioning Problem 4
Device Operates Differently Than Expected 4
Appropriate Term/Code Not Available 2
Break 2
Insufficient Information 2
Leak / Splash 2
Unintended Collision 2
Unintended Movement 2
Device Handling Problem 2
Off-Label Use 1
Protective Measures Problem 1
Misassembly by Users 1
Cover 1
Overheating of Device 1
Interface 1
Component Falling 1
Device Tipped Over 1
Activation, Positioning or Separation Problem 1
Degraded 1
Smoking 1
Detector 1
Inadequate Service 1
Human-Device Interface Problem 1
Material Integrity Problem 1
Total Device Problems 63

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Sep-21-2015
2 GE Healthcare II Mar-13-2015
3 GE Healthcare, LLC II Jun-19-2019
4 GE Healthcare, LLC II Jan-09-2019
5 GE Healthcare, LLC II Dec-13-2018
6 GE Healthcare, LLC I Nov-14-2018
7 GE Healthcare, LLC II Jul-31-2018
8 GE Healthcare, LLC II Jun-12-2017
9 GE Healthcare, LLC II Dec-16-2014
10 GE Healthcare, LLC II Mar-13-2014
11 GE Healthcare, LLC II Feb-14-2014
12 GE Medical Systems, LLC II Mar-04-2016
13 Philips Medical Systems (Cleveland) Inc II Jul-22-2019
14 Philips Medical Systems (Cleveland) Inc II Jul-03-2019
15 Philips Medical Systems (Cleveland) Inc II Feb-12-2019
16 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
17 Philips Medical Systems (Cleveland) Inc II Jul-19-2018
18 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
19 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
20 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
21 Philips Medical Systems (Cleveland) Inc II Feb-03-2018
22 Philips Medical Systems (Cleveland) Inc II Apr-06-2017
23 Philips Medical Systems (Cleveland) Inc III Apr-06-2017
24 Philips Medical Systems (Cleveland) Inc II Mar-16-2017
25 Philips Medical Systems (Cleveland) Inc II Feb-10-2017
26 Philips Medical Systems (Cleveland) Inc II Sep-03-2016
27 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
28 Philips Medical Systems (Cleveland) Inc II Feb-26-2016
29 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
30 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
31 Philips Medical Systems (Cleveland) Inc II May-28-2015
32 Philips Medical Systems (Cleveland) Inc II May-12-2015
33 Philips Medical Systems (Cleveland) Inc II Jan-26-2015
34 Philips Medical Systems (Cleveland) Inc II Dec-01-2014
35 Philips Medical Systems (Cleveland) Inc II Jul-10-2014
36 Philips Medical Systems (Cleveland) Inc II Jul-02-2014
37 Philips Medical Systems (Cleveland) Inc II Jun-02-2014
38 Philips Medical Systems (Cleveland) Inc II Apr-26-2014
39 Philips Medical Systems (Cleveland) Inc II Apr-16-2014
40 Philips Medical Systems (Cleveland) Inc II Feb-24-2014
41 Philips Medical Systems (Cleveland) Inc II Feb-12-2014
42 Philips Medical Systems (Cleveland) Inc II Feb-04-2014
43 Philips Medical Systems, Inc. II Dec-12-2014
44 Siemens Medical Solutions USA Inc. II Feb-28-2017
45 Siemens Medical Solutions USA Inc. II Jan-10-2017
46 Siemens Medical Solutions USA Inc. II Jun-21-2016
47 Siemens Medical Solutions USA Inc. II Jun-15-2016
48 Siemens Medical Solutions USA Inc. II Aug-05-2015
49 Siemens Medical Solutions USA Inc. II Dec-16-2014
50 Siemens Medical Solutions USA, Inc. II Jan-10-2019
51 Siemens Medical Solutions USA, Inc. II Nov-02-2018
52 Siemens Medical Solutions USA, Inc. II Oct-18-2018
53 Siemens Medical Solutions USA, Inc. II May-24-2018
54 Siemens Medical Solutions USA, Inc. II Nov-16-2017
55 Siemens Medical Solutions USA, Inc. II Oct-25-2017
56 Siemens Medical Solutions USA, Inc. II Oct-08-2016
57 Siemens Medical Solutions USA, Inc. II Mar-25-2016
58 Siemens Medical Solutions USA, Inc. II Nov-04-2015
59 Siemens Medical Solutions USA, Inc. II Aug-20-2015
60 Siemens Medical Solutions USA, Inc. II Mar-19-2015
61 Siemens Medical Solutions USA, Inc. II Feb-10-2015
62 Siemens Medical Solutions USA, Inc. II Jan-13-2015
63 Siemens Medical Solutions USA, Inc. II Jan-06-2015
64 Siemens Medical Solutions USA, Inc. II Jan-06-2015
65 Siemens Medical Solutions USA, Inc. II Oct-22-2014
66 Siemens Medical Solutions USA, Inc. II Sep-29-2014
67 Siemens Medical Solutions USA, Inc. II Jul-11-2014
68 Toshiba American Medical Systems Inc II Oct-06-2016
69 Toshiba American Medical Systems Inc II May-04-2016
70 Toshiba American Medical Systems Inc II Oct-07-2015

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