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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2050
Electrical issue 1184
Device inoperable 941
Device displays error message 780
Communication or transmission issue 509
Computer software issue 356
Difficult to open or close 236
Mechanical issue 203
Poor quality image 146
Device stops intermittently 139
Incorrect display 127
No display or display failure 90
Application interface becomes non-functional or program exits abnormally 83
Calibration issue 76
Material deformation 60
No device output 52
Break 41
Device emits odor 31
Positioning Issue 26
Burn of device or device component 24
Imprecision 21
Application program issue 21
No Known Device Problem 19
Unintended movement 18
Improper device output 16
Spark 14
Use of Device Issue 14
Failure to calibrate 14
Naturally worn 8
Device or device component damaged by another device 8
Device sensing issue 7
Bent 7
Dose calculation error due to software problem 6
Device Issue 6
Failure to fire 6
Unstable 6
Image reversal 5
Fracture 5
Erratic display 3
Output issue 3
Issue with displayed error message 2
Battery issue 2
Device clogged 2
Patient-device incompatibility 2
Low battery 1
Smoking 1
Unintended collision 1
Melted 1
Unintended arm motion 1
Charred 1
Material frayed 1
Image display error 1
Image resolution poor 1
Loose or intermittent connection 1
Electronic property issue 1
Power source issue 1
No code available 1
Noise, Audible 1
Total Device Problems 7383

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 2
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 Feb-27-2017
4 GE OEC Medical Systems, Inc II Jan-09-2017
5 GE OEC Medical Systems, Inc II Oct-11-2016
6 GE OEC Medical Systems, Inc II Jun-08-2015
7 GE OEC Medical Systems, Inc II Jan-13-2015
8 GE OEC Medical Systems, Inc II Nov-07-2014
9 GE OEC Medical Systems, Inc II Aug-23-2012
10 GE OEC Medical Systems, Inc II Aug-22-2012
11 GE OEC Medical Systems, Inc I Jul-24-2012
12 GE OEC Medical Systems, Inc I Jul-24-2012
13 GE OEC Medical Systems, Inc II Jul-18-2012
14 Medtronic Navigation, Inc. II Feb-28-2014
15 Medtronic Navigation, Inc. II Mar-08-2013
16 Medtronic Navigation, Inc. II Aug-22-2012
17 Medtronic Navigation, Inc.-Littleton II Jul-06-2016

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