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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 136
Device operates differently than expected 108
Electrical issue 96
Device displays error message 72
Communication or transmission issue 48
Device stops intermittently 36
Application interface becomes non-functional or program exits abnormally 36
Mechanical issue 25
Computer software issue 24
No display or display failure 21
Material deformation 17
Burn of device or device component 16
Device emits odor 16
Incorrect display 11
Improper device output 9
Failure to fire 6
Spark 5
Dose calculation error due to software problem 5
Break 5
Imprecision 5
Unintended movement 5
No device output 4
Device Issue 4
No Known Device Problem 3
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
Noise, Audible 1
Total Device Problems 738

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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