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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 372
Device operates differently than expected 260
Device displays error message 216
Electrical issue 214
Communication or transmission issue 131
Mechanical issue 67
Computer software issue 66
Device stops intermittently 63
Application interface becomes non-functional or program exits abnormally 61
No display or display failure 34
Difficult to open or close 32
Incorrect display 24
No device output 23
Material deformation 22
Device emits odor 18
Burn of device or device component 17
Imprecision 16
Improper device output 12
No Known Device Problem 10
Calibration issue 9
Spark 7
Failure to fire 6
Break 6
Unintended movement 6
Dose calculation error due to software problem 5
Use of Device Issue 5
Device Issue 4
Application program issue 3
Unstable 3
Device or device component damaged by another device 3
Device sensing issue 3
Issue with displayed error message 2
Output issue 2
Device clogged 2
Battery issue 2
Bent 2
Image reversal 2
Fracture 2
Material frayed 1
Image display error 1
Loose or intermittent connection 1
Melted 1
Charred 1
Erratic display 1
Patient-device incompatibility 1
Unintended collision 1
Smoking 1
Positioning Issue 1
Power source issue 1
Noise, Audible 1
Naturally worn 1
Total Device Problems 1745

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 1
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 Jun-08-2015
4 GE OEC Medical Systems, Inc II Jan-13-2015
5 GE OEC Medical Systems, Inc II Nov-07-2014
6 GE OEC Medical Systems, Inc II Aug-23-2012
7 GE OEC Medical Systems, Inc II Aug-22-2012
8 GE OEC Medical Systems, Inc I Jul-24-2012
9 GE OEC Medical Systems, Inc I Jul-24-2012
10 GE OEC Medical Systems, Inc II Jul-18-2012
11 Medtronic Navigation, Inc. II Feb-28-2014
12 Medtronic Navigation, Inc. II Mar-08-2013
13 Medtronic Navigation, Inc. II Aug-22-2012
14 Medtronic Navigation, Inc.-Littleton II Jul-06-2016

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