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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GE OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GEMSS MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSCAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Operates Differently Than Expected 3442
Electrical /Electronic Property Problem 1833
Device Displays Incorrect Message 1149
Device Inoperable 1077
Communication or Transmission Problem 982
Application Program Freezes, Becomes Nonfunctional 954
Battery 752
Computer Software Problem 500
Cable 416
Difficult to Open or Close 378
Fuse 351
Mechanical Problem 331
Poor Quality Image 324
Circuit Board 306
Device Stops Intermittently 253
Application Interface Becomes Non-Functional Or Program Exits Abnormally 233
Positioning Problem 226
Material Deformation 209
Display or Visual Feedback Problem 190
Failure to Run on Battery 183
Charger 172
Failure to Power Up 170
Calibration Problem 168
CPU (Central Processing Unit Of Computer System) 164
No Display / Image 150
Cover 144
Unexpected Shutdown 126
Noise, Audible 115
Failure to Charge 107
Imprecision 103
Adverse Event Without Identified Device or Use Problem 82
Break 75
Computer Hardware 73
Use of Device Problem 67
Controller 62
No Device Output 58
Monitor 52
Connector 48
Application Program Problem 47
Physical Resistance / Sticking 45
Power Cord 43
Device Emits Odor 39
Device Sensing Problem 36
Power Switch 34
Unintended Movement 33
Smoking 27
Image Display Error / Artifact 26
Thermal Decomposition of Device 25
Wireless Communication Problem 24
Detector 21
Sparking 20
Power Problem 17
Failure to Calibrate 17
Electrical Wire 16
Failure to Obtain Sample 16
Failure to Fire 15
Keyboard 15
Improper Device Output 15
Arcing 14
Insufficient Information 13
Hinge 13
Bent 12
Data Problem 12
LED (Light Emitting Diode) 11
Device Damaged by Another Device 11
Display 11
Motherboard 10
Unstable 10
Pin 10
Fracture 9
Naturally Worn 9
Frame 9
Premature Discharge of Battery 9
Connection Problem 8
Erratic or Intermittent Display 7
Emergency Stop Button Or Switch 7
Unintended Electrical Shock 7
Spring 6
Overheating of Device 6
Unintended Application Program Shut Down 6
Output Problem 5
Material Frayed 5
Image Reversal 5
Screw 5
Battery Problem 5
Intermittent loss of power 5
Component Missing 4
Loose or Intermittent Connection 3
Foot Switch 3
Handpiece 3
Caster 3
Fan 3
Human-Device Interface Problem 3
Device Issue 3
Loss of Power 3
Material Twisted / Bent 3
Motor 3
Unexpected/Unintended Radiation Output 2
Environmental Compatibility Problem 2
Complete Blockage 2
Total Device Problems 16836

Recalls
Manufacturer Recall Class Date Posted
1 GE OEC Medical Systems, Inc II Feb-27-2017
2 GE OEC Medical Systems, Inc II Jan-09-2017
3 GE OEC Medical Systems, Inc II Oct-11-2016
4 GE OEC Medical Systems, Inc II Jun-08-2015
5 GE OEC Medical Systems, Inc II Jan-13-2015
6 Medtronic Navigation, Inc.-Littleton II Jul-03-2019
7 Medtronic Navigation, Inc.-Littleton II Oct-25-2018
8 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
9 Medtronic Navigation, Inc.-Littleton II Jul-06-2016
10 Orthoscan, Inc. II Jan-09-2018

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