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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 2297
Electrical issue 1260
Device inoperable 972
Device displays error message 827
Communication or transmission issue 535
Computer software issue 372
Difficult to open or close 260
Mechanical issue 215
Poor quality image 154
Device stops intermittently 148
Incorrect display 147
Application interface becomes non-functional or program exits abnormally 93
No display or display failure 92
Calibration issue 87
Material deformation 71
No device output 52
Break 45
Device emits odor 32
Positioning Issue 32
Burn of device or device component 26
Imprecision 23
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 14
Device or device component damaged by another device 9
Naturally worn 8
Device sensing issue 7
Unstable 7
Bent 7
Dose calculation error due to software problem 6
Fracture 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
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
Electronic property issue 1
Power source issue 1
No code available 1
Noise, Audible 1
Total Device Problems 7957

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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