• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device calculator/data processing module, for clinical use
Regulation Description Calculator/data processing module for clinical use.
Product CodeJQP
Regulation Number 862.2100
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 5
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Issue 64
Output issue 48
Problem with software installation 33
Computer software issue 28
Incorrect or inadequate result 25
No Known Device Problem 21
Patient Data Issue 20
Data Issue 17
High test results 15
Device operates differently than expected 13
Charred 10
Programming issue 9
Device Issue 8
Improper or incorrect procedure or method 8
False negative result 6
Burn of device or device component 6
Melted 5
Incorrect software programming calculations 5
Incorrect or inadequate test results 5
Application program issue 5
Low test results 4
Mechanical issue 3
Smoking 3
Device handling issue 3
Use of Incorrect Control Settings 2
Dose calculation error due to software problem 1
Fire 1
Component(s), worn 1
Contamination during use 1
Device emits odor 1
Unintended system motion 1
Overheating of device or device component 1
Spark 1
Failure to fire 1
Implant Mobility NOS (Not otherwise specified) 1
Connection issue 1
Loss of Data 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Prompts will not clear 1
Defective component 1
Malfunction 1
Metal shedding debris 1
Scratched material 1
No code available 1
Device sensing issue 1
Material integrity issue 1
Positioning Issue 1
Total Device Problems 389

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 3 6 6 5 6 14 5 12 10 5 6
Class III 0 0 0 1 0 6 2 3 1 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Sep-18-2009
2 Abbott Laboratories, Inc II Feb-05-2009
3 Abbott Laboratories, Inc II Jan-25-2008
4 Abbott Laboratories, Inc II Nov-24-2007
5 Abbott Laboratories, Inc II Jul-03-2007
6 Abbott Point of Care Inc. II Feb-26-2010
7 Beckman Coulter Inc II Jan-09-2007
8 Beckman Coulter Inc. III Jan-18-2017
9 Becton Dickinson & Co. II Feb-27-2017
10 Cerner Corp II May-01-2009
11 Data Innovations, Inc. II Dec-24-2013
12 Data Innovations, Inc. II Oct-21-2011
13 Data Innovations, LLC II Feb-16-2017
14 Data Innovations, LLC II Sep-12-2014
15 GE Healthcare Integrated IT Solutions II May-15-2009
16 GE Healthcare Integrated IT Solutions II Dec-31-2008
17 GE Healthcare It II Aug-26-2016
18 GE Healthcare It III Jan-29-2014
19 GE Healthcare It II Jan-02-2014
20 GE Healthcare It II Nov-15-2013
21 GE Healthcare It II Jun-24-2013
22 Ge Healthcare It III Jun-26-2015
23 Ge Healthcare It II Jun-14-2011
24 Ge Healthcare It II Feb-15-2011
25 Ge Healthcare It II Oct-22-2010
26 Horiba Instruments, Inc dba Horiba Medical II Mar-11-2014
27 Horiba Instruments, Inc dba Horiba Medical III Apr-03-2013
28 Horiba Instruments, Inc dba Horiba Medical II Jan-07-2013
29 International Technidyne Corporation III Sep-20-2010
30 McKesson Technologies, Inc. II Jul-27-2015
31 Medical Information Technology, Inc. II Mar-19-2014
32 Medical Information Technology, Inc. II Mar-03-2014
33 Medical Information Technology, Inc. II Apr-26-2012
34 Merge Healthcare, Inc. II Nov-11-2016
35 Microsoft Corporation Health Solutions Group III Jun-04-2012
36 Microsoft Corporation Health Solutions Group II Mar-08-2012
37 Microsoft Corporation Health Solutions Group II Feb-22-2012
38 Microsoft Corporation Health Solutions Group II Jan-11-2012
39 Perkin Elmer II Aug-25-2009
40 Perkin Elmer Life Sciences Inc II Oct-26-2015
41 PerkinElmer Health Sciences, Inc. II Dec-23-2016
42 PerkinElmer Health Sciences, Inc. II Aug-07-2014
43 PerkinElmer Life and Analytical Sciences, Wallac, OY II Mar-13-2017
44 Radiometer America Inc II Sep-06-2014
45 Roche Diabetes Care, Inc. II Apr-02-2015
46 Roche Diagnostics Corp. II May-20-2009
47 Roche Diagnostics Corporation II Mar-23-2017
48 Roche Diagnostics Corporation II Jan-24-2017
49 Roche Diagnostics Operations, Inc. II Oct-25-2016
50 Roche Diagnostics Operations, Inc. II Mar-23-2016
51 Roche Diagnostics Operations, Inc. II Nov-18-2015
52 Roche Diagnostics Operations, Inc. II Sep-01-2014
53 SCC Soft Computer II Feb-09-2015
54 SCC Soft Computer II Feb-02-2015
55 SCC Soft Computer II May-09-2014
56 SCC Soft Computer II Aug-03-2012
57 SCC Soft Computer II Jan-11-2012
58 SCC Soft Computer II Jan-11-2012
59 SCC Soft Computer III Jan-11-2012
60 SCC Soft Computer II Dec-02-2011
61 SCC Soft Computer II Nov-21-2011
62 SCC Soft Computer II Nov-17-2011
63 SCC Soft Computer II Nov-16-2010
64 SCC Soft Computer II Nov-15-2010
65 SCC Soft Computer II Nov-10-2010
66 SCC Soft Computer II Sep-22-2008
67 SCC Soft Computer II Sep-22-2008
68 Siemens Healthcare Diagnostics Inc III Jul-17-2014
69 Siemens Healthcare Diagnostics, Inc. II Feb-15-2017
70 Siemens Healthcare Diagnostics, Inc. II Jul-02-2015
71 Siemens Healthcare Diagnostics, Inc. II Jun-30-2015
72 Siemens Healthcare Diagnostics, Inc. II Jan-15-2015
73 Siemens Healthcare Diagnostics, Inc. II Sep-01-2014
74 Siemens Healthcare Diagnostics, Inc. II Jun-30-2014
75 Siemens Healthcare Diagnostics, Inc. II Jan-24-2014
76 Siemens Healthcare Diagnostics, Inc. II Aug-31-2012
77 Siemens Healthcare Diagnostics, Inc. II Aug-22-2012
78 Sunquest Information Systems, Inc. II Nov-06-2012
79 Sunquest Information Systems, Inc. II Nov-06-2012
80 Sunquest Information Systems, Inc. III Oct-17-2012
81 Sunquest Information Systems, Inc. II Sep-07-2012
82 Sunquest Information Systems, Inc. II Aug-24-2012
83 Sunquest Information Systems, Inc. II Aug-24-2012
84 Sunquest Information Systems, Inc. III Aug-22-2012
85 Sunquest Information Systems, Inc. III Aug-21-2012
86 Sunquest Information Systems, Inc. III Aug-16-2012
87 Sunquest Information Systems, Inc. II Nov-12-2008
88 Sunquest Information Systems, Inc. II Oct-31-2008
89 Technidata S.A. III Mar-31-2014
90 Technidata S.A. III Jul-17-2013
91 Technidata S.A. II May-21-2013
92 bioMerieux, Inc. II Dec-16-2015

-
-