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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 2355
Electrical issue 1301
Device inoperable 982
Device displays error message 847
Communication or transmission issue 552
Computer software issue 378
Difficult to open or close 266
Mechanical issue 218
Poor quality image 155
Incorrect display 152
Device stops intermittently 152
Calibration issue 96
Application interface becomes non-functional or program exits abnormally 95
No display or display failure 92
Material deformation 71
No device output 52
Break 46
Device emits odor 35
Positioning Issue 32
Imprecision 27
Burn of device or device component 26
Application program issue 23
No Known Device Problem 19
Unintended movement 18
Improper device output 16
Failure to calibrate 16
Use of Device Issue 15
Spark 15
Unstable 9
Device or device component damaged by another device 9
Naturally worn 8
Device sensing issue 7
Bent 7
Fracture 7
Dose calculation error due to software problem 6
Failure to fire 6
Device Issue 6
Image reversal 5
Erratic display 4
Output issue 3
Issue with displayed error message 2
Battery issue 2
No Information 2
Device clogged 2
Patient-device incompatibility 2
Low battery 1
Smoking 1
Unintended collision 1
Melted 1
Unintended arm motion 1
Charred 1
Loose or intermittent connection 1
Material frayed 1
Image display error 1
Image resolution poor 1
No code available 1
Noise, Audible 1
Electronic property issue 1
Power source issue 1
Total Device Problems 8153

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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