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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 90
Device operates differently than expected 90
Electrical issue 71
Device displays error message 53
Communication or transmission issue 40
Device stops intermittently 30
Application interface becomes non-functional or program exits abnormally 29
No display or display failure 19
Mechanical issue 18
Computer software issue 17
Device emits odor 15
Burn of device or device component 14
Material deformation 12
Incorrect display 9
Improper device output 8
Failure to fire 6
Spark 5
Dose calculation error due to software problem 5
Break 5
Imprecision 5
No device output 4
Device Issue 4
Unintended movement 4
Output issue 2
Issue with displayed error message 2
Battery issue 2
Unstable 2
Fracture 2
Image display error 1
Image reversal 1
Loose or intermittent connection 1
Unintended collision 1
Melted 1
Bent 1
Charred 1
Use of Device Issue 1
Smoking 1
Calibration issue 1
Patient-device incompatibility 1
Application program issue 1
Power source issue 1
Naturally worn 1
No Known Device Problem 1
Noise, Audible 1
Total Device Problems 579

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 0
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

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