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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CEDARS-SINAI MEDICAL CENTER
  SUBSTANTIALLY EQUIVALENT 1
DDD-DIAGNOSTIC A/S
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 4
HERMES MEDICAL SOLUTIONS, AB
  SUBSTANTIALLY EQUIVALENT 1
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Misassembled During Installation 29
Use of Device Problem 11
Improper or Incorrect Procedure or Method 8
Adverse Event Without Identified Device or Use Problem 8
Mechanical Problem 5
Positioning Problem 4
Device Operates Differently Than Expected 3
Unintended Collision 2
Unintended Movement 2
Insufficient Information 2
Appropriate Term/Code Not Available 2
Device Handling Problem 2
Misassembly by Users 1
Off-Label Use 1
Inadequate Service 1
Cover 1
Detector 1
Break 1
Component Falling 1
Degraded 1
Leak / Splash 1
Material Integrity Problem 1
Protective Measures Problem 1
Device Tipped Over 1
Application Program Version or Upgrade Problem 1
Activation, Positioning or Separation Problem 1
Total Device Problems 92

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 Medical Systems, LLC II Mar-04-2016
10 Philips Medical Systems (Cleveland) Inc I Nov-01-2019
11 Philips Medical Systems (Cleveland) Inc II Jul-22-2019
12 Philips Medical Systems (Cleveland) Inc II Jul-03-2019
13 Philips Medical Systems (Cleveland) Inc II Feb-12-2019
14 Philips Medical Systems (Cleveland) Inc II Oct-31-2018
15 Philips Medical Systems (Cleveland) Inc II Jul-19-2018
16 Philips Medical Systems (Cleveland) Inc II Jun-22-2018
17 Philips Medical Systems (Cleveland) Inc II Apr-17-2018
18 Philips Medical Systems (Cleveland) Inc II Feb-04-2018
19 Philips Medical Systems (Cleveland) Inc II Feb-03-2018
20 Philips Medical Systems (Cleveland) Inc II Apr-06-2017
21 Philips Medical Systems (Cleveland) Inc III Apr-06-2017
22 Philips Medical Systems (Cleveland) Inc II Mar-16-2017
23 Philips Medical Systems (Cleveland) Inc II Feb-10-2017
24 Philips Medical Systems (Cleveland) Inc II Sep-03-2016
25 Philips Medical Systems (Cleveland) Inc II Apr-15-2016
26 Philips Medical Systems (Cleveland) Inc II Feb-26-2016
27 Philips Medical Systems (Cleveland) Inc II Jul-22-2015
28 Philips Medical Systems (Cleveland) Inc II Jun-11-2015
29 Philips Medical Systems (Cleveland) Inc II May-28-2015
30 Philips Medical Systems (Cleveland) Inc II May-12-2015
31 Philips Medical Systems (Cleveland) Inc II Jan-26-2015
32 Siemens Medical Solutions USA Inc. II Feb-28-2017
33 Siemens Medical Solutions USA Inc. II Jan-10-2017
34 Siemens Medical Solutions USA Inc. II Jun-21-2016
35 Siemens Medical Solutions USA Inc. II Jun-15-2016
36 Siemens Medical Solutions USA Inc. II Aug-05-2015
37 Siemens Medical Solutions USA, Inc. II Jan-10-2019
38 Siemens Medical Solutions USA, Inc. II Nov-02-2018
39 Siemens Medical Solutions USA, Inc. II Oct-18-2018
40 Siemens Medical Solutions USA, Inc. II May-24-2018
41 Siemens Medical Solutions USA, Inc. II Nov-16-2017
42 Siemens Medical Solutions USA, Inc. II Oct-25-2017
43 Siemens Medical Solutions USA, Inc. II Oct-08-2016
44 Siemens Medical Solutions USA, Inc. II Mar-25-2016
45 Siemens Medical Solutions USA, Inc. II Nov-04-2015
46 Siemens Medical Solutions USA, Inc. II Aug-20-2015
47 Siemens Medical Solutions USA, Inc. II Mar-19-2015
48 Siemens Medical Solutions USA, Inc. II Feb-10-2015
49 Siemens Medical Solutions USA, Inc. II Jan-13-2015
50 Siemens Medical Solutions USA, Inc. II Jan-06-2015
51 Siemens Medical Solutions USA, Inc. II Jan-06-2015
52 Toshiba American Medical Systems Inc II Oct-06-2016
53 Toshiba American Medical Systems Inc II May-04-2016
54 Toshiba American Medical Systems Inc II Oct-07-2015

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