• 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 image-intensified fluoroscopic x-ray system, mobile
Regulation Description Image-intensified fluoroscopic x-ray system.
Definition Fluoroscopy of the human body.
Product CodeOXO
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 7
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OEC-DIASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1784
Electrical issue 1100
Device inoperable 918
Device displays error message 724
Communication or transmission issue 480
Computer software issue 320
Difficult to open or close 212
Mechanical issue 191
Poor quality image 138
Device stops intermittently 123
Incorrect display 87
No display or display failure 86
Application interface becomes non-functional or program exits abnormally 83
Calibration issue 66
No device output 52
Material deformation 52
Break 40
Device emits odor 28
Positioning Issue 24
Burn of device or device component 24
Application program issue 21
Imprecision 20
No Known Device Problem 19
Improper device output 16
Spark 13
Failure to calibrate 13
Use of Device Issue 13
Unintended movement 13
Naturally worn 8
Device or device component damaged by another device 7
Bent 7
Device sensing issue 7
Unstable 6
Failure to fire 6
Dose calculation error due to software problem 6
Device Issue 6
Image reversal 5
Fracture 5
Output issue 3
Erratic display 3
Device clogged 2
Patient-device incompatibility 2
Battery issue 2
Issue with displayed error message 2
Image resolution poor 1
Power source issue 1
Electronic property issue 1
Material frayed 1
Smoking 1
Melted 1
No code available 1
Unintended collision 1
Image display error 1
Low battery 1
Loose or intermittent connection 1
Unintended arm motion 1
Charred 1
Noise, Audible 1
Total Device Problems 6751

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

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD II Oct-24-2013
2 GE Healthcare, LLC II Nov-16-2012
3 GE OEC Medical Systems, Inc II Jan-09-2017
4 GE OEC Medical Systems, Inc II Oct-11-2016
5 GE OEC Medical Systems, Inc II Jun-08-2015
6 GE OEC Medical Systems, Inc II Jan-13-2015
7 GE OEC Medical Systems, Inc II Nov-07-2014
8 GE OEC Medical Systems, Inc II Aug-23-2012
9 GE OEC Medical Systems, Inc II Aug-22-2012
10 GE OEC Medical Systems, Inc I Jul-24-2012
11 GE OEC Medical Systems, Inc I Jul-24-2012
12 GE OEC Medical Systems, Inc II Jul-18-2012
13 Medtronic Navigation, Inc. II Feb-28-2014
14 Medtronic Navigation, Inc. II Mar-08-2013
15 Medtronic Navigation, Inc. II Aug-22-2012
16 Medtronic Navigation, Inc.-Littleton II Jul-06-2016

-
-