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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 inoperable 526
Device operates differently than expected 467
Electrical issue 393
Device displays error message 304
Communication or transmission issue 200
Computer software issue 122
Mechanical issue 100
Device stops intermittently 87
Application interface becomes non-functional or program exits abnormally 74
Difficult to open or close 58
No display or display failure 57
No device output 35
Material deformation 34
Incorrect display 33
Device emits odor 24
Burn of device or device component 22
Poor quality image 21
Break 18
Imprecision 18
Calibration issue 15
Improper device output 13
Application program issue 11
No Known Device Problem 10
Unintended movement 9
Spark 9
Use of Device Issue 8
Device or device component damaged by another device 7
Device Issue 6
Failure to fire 6
Dose calculation error due to software problem 6
Positioning Issue 5
Device sensing issue 4
Unstable 4
Image reversal 4
Fracture 3
Bent 3
Failure to calibrate 3
Output issue 3
Issue with displayed error message 2
Battery issue 2
Device clogged 2
Erratic display 2
Unintended arm motion 1
Charred 1
Material frayed 1
Image display error 1
Image resolution poor 1
Loose or intermittent connection 1
Low battery 1
Patient-device incompatibility 1
Smoking 1
Unintended collision 1
Melted 1
Electronic property issue 1
Naturally worn 1
Power source issue 1
No code available 1
Noise, Audible 1
Total Device Problems 2746

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 2 0 0 0 0
Class II 0 0 0 0 0 5 2 2 2 2
Class III 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 Oct-11-2016
4 GE OEC Medical Systems, Inc II Jun-08-2015
5 GE OEC Medical Systems, Inc II Jan-13-2015
6 GE OEC Medical Systems, Inc II Nov-07-2014
7 GE OEC Medical Systems, Inc II Aug-23-2012
8 GE OEC Medical Systems, Inc II Aug-22-2012
9 GE OEC Medical Systems, Inc I Jul-24-2012
10 GE OEC Medical Systems, Inc I Jul-24-2012
11 GE OEC Medical Systems, Inc II Jul-18-2012
12 Medtronic Navigation, Inc. II Feb-28-2014
13 Medtronic Navigation, Inc. II Mar-08-2013
14 Medtronic Navigation, Inc. II Aug-22-2012
15 Medtronic Navigation, Inc.-Littleton II Jul-06-2016

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