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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 6
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 64
Device inoperable 44
Electrical issue 31
Communication or transmission issue 28
Device displays error message 26
Application interface becomes non-functional or program exits abnormally 23
Device stops intermittently 20
No display or display failure 15
Device emits odor 14
Burn of device or device component 13
Mechanical issue 13
Computer software issue 10
Material deformation 10
Improper device output 7
Dose calculation error due to software problem 5
Imprecision 5
Break 5
Incorrect display 5
No device output 4
Device Issue 4
Spark 4
Unintended movement 3
Output issue 2
Unstable 2
Battery issue 2
Issue with displayed error message 2
Power source issue 1
Patient-device incompatibility 1
Bent 1
No Known Device Problem 1
Melted 1
Smoking 1
Use of Device Issue 1
Noise, Audible 1
Charred 1
Calibration issue 1
Naturally worn 1
Loose or intermittent connection 1
Image display error 1
Unintended collision 1
Application program issue 1
Image reversal 1
Total Device Problems 377

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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