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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device computer, diagnostic, programmable
Regulation Description Programmable diagnostic computer.
Product CodeDQK
Regulation Number 870.1425
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 12
ADAMS MEDITECH LLC
  SUBSTANTIALLY EQUIVALENT 1
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 7
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CARDIOINSIGHT TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
CARDIOTEK, B.V.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GETEMED
  SUBSTANTIALLY EQUIVALENT 1
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MCKESSON MEDICAL IMAGING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERGE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Communication or Transmission Problem 119
Application Interface Becomes Non-Functional Or Program Exits Abnormally 112
Device Issue 90
Device Operational Issue 88
Failure to Transmit Record 73
Data Problem 65
Image Orientation Incorrect 46
Computer Software Problem 40
Application Program Problem 37
Device Operates Differently Than Expected 34
No Display / Image 34
Retraction Problem 32
EKG/ECG Monitor 27
Blocked Connection 25
Device Displays Incorrect Message 25
Adverse Event Without Identified Device or Use Problem 22
Failure to Power Up 21
Pacing Problem 20
Erratic or Intermittent Display 19
Incorrect Measurement 19
Power Problem 18
Cable 17
Signal Artifact 16
Output Problem 16
Insufficient Information 15
Improper Device Output 15
Failure to Cycle 14
Connection Problem 14
Failure of Device to Self-Test 14
Noise, Audible 13
Overheating of Device 13
Display or Visual Feedback Problem 13
Use of Device Problem 13
Smoking 11
Loss of Data 11
Patient Data Problem 11
Appropriate Term/Code Not Available 8
Application Program Freezes, Becomes Nonfunctional 8
Battery Problem 7
Difficult to Remove 7
Device Component Or Accessory 6
Battery 6
Intermittent Communication Failure 6
Image Display Error / Artifact 6
Fuse 6
Monitor 6
Incorrect, Inadequate or Imprecise Result or Readings 6
Computer Hardware 6
Disconnection 5
Device Alarm System 5
No Apparent Adverse Event 5
Sparking 5
No Pacing 4
Electrical /Electronic Property Problem 4
Failure to Zero 4
Computer Operating System Problem 4
Device Emits Odor 4
Application Network Problem 3
Interface 3
Connector 3
Loose or Intermittent Connection 3
Break 3
EKG/ECG Subassembly (Only Use When Part Of Another Device) 3
Bent 3
Inappropriate Shock 3
Failure to Read Input Signal 3
Device Stops Intermittently 3
Decoupling 2
Electronic Property Issue 2
Application Program Version or Upgrade Problem 2
Inaccurate Synchronization 2
Fire 2
High Readings 2
No Device Output 2
Temperature Problem 2
Calibration Problem 2
Missing Value Reason 2
Malposition of device 2
Impedance Problem 2
Connector Pin 2
Use of Incorrect Control Settings 2
Arcing 2
Material Deformation 2
Failure to Obtain Sample 1
Device Contamination with Chemical or Other Material 1
Detachment Of Device Component 1
Power Cord 1
Transducer 1
Keyboard 1
Recorder (Tape, Stripchart, Etc.) 1
Generator 1
Radio Signal Problem 1
Human Factors Issue 1
Installation-Related Problem 1
Operating System Version or Upgrade Problem 1
Unexpected Shutdown 1
Lead 1
Pacing Asynchronously 1
Failure to Select Signal 1
Moisture Damage 1
Total Device Problems 1369

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Sep-09-2016
2 Biosense Webster, Inc. II Oct-01-2015
3 Biosense Webster, Inc. II Feb-20-2014
4 CardioTek BV II Jun-30-2017
5 Change Healthcare Israel Ltd. II May-24-2019
6 Edwards Lifesciences, LLC II Jan-16-2018
7 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
8 Fujifilm Medical Systems U.S.A., Inc. II May-14-2015
9 GE Healthcare Finland Oy II Oct-10-2018
10 GE Healthcare Finland Oy II Jul-02-2018
11 GE Healthcare, LLC II Jul-23-2019
12 GE Medical Systems Information Technologies, Inc. II Jan-25-2018
13 Hitachi Healthcare Americas Corp Informatics Division II Sep-06-2018
14 Invivo Corporation II Nov-14-2018
15 McKesson Israel Ltd. II Aug-31-2018
16 McKesson Israel Ltd. II Jan-05-2015
17 Merge Healthcare, Inc. II Jan-14-2018
18 Merge Healthcare, Inc. II Jul-10-2017
19 Merge Healthcare, Inc. II Jun-29-2017
20 Merge Healthcare, Inc. II May-02-2017
21 Merge Healthcare, Inc. II Apr-11-2017
22 Merge Healthcare, Inc. II Mar-14-2017
23 Merge Healthcare, Inc. II Feb-15-2017
24 Merge Healthcare, Inc. II Jan-24-2017
25 Merge Healthcare, Inc. II Nov-28-2016
26 Merge Healthcare, Inc. II Aug-04-2016
27 Merge Healthcare, Inc. II Dec-28-2015
28 Merge Healthcare, Inc. II Aug-06-2015
29 Merge Healthcare, Inc. II Oct-28-2014
30 Philips Electronics North America Corporation II Dec-14-2018
31 Philips Medical Systems, Inc. II Aug-21-2014
32 Siemens Medical Solutions USA, Inc II Feb-23-2019
33 Siemens Medical Solutions USA, Inc II Jul-06-2017
34 Siemens Medical Solutions USA, Inc II May-24-2017
35 Spacelabs Healthcare, Inc. II Jul-22-2019
36 Spacelabs Healthcare, Llc II Mar-25-2014

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