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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
GE OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEMSS MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSCAN, INC.
  SUBSTANTIALLY EQUIVALENT 2
SKANRAY TECHNOLOGIES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Operates Differently Than Expected 3446
Electrical /Electronic Property Problem 1830
Device Displays Incorrect Message 1148
Device Inoperable 1077
Communication or Transmission Problem 932
Battery 752
Application Program Freezes, Becomes Nonfunctional 657
Computer Software Problem 500
Cable 416
Difficult to Open or Close 378
Fuse 351
Mechanical Problem 330
Circuit Board 306
Poor Quality Image 303
Device Stops Intermittently 254
Application Interface Becomes Non-Functional Or Program Exits Abnormally 234
Display or Visual Feedback Problem 193
Material Deformation 192
Charger 172
CPU (Central Processing Unit Of Computer System) 164
Calibration Problem 162
Positioning Problem 161
Cover 144
No Display / Image 143
Failure to Run on Battery 135
Failure to Power Up 126
Unexpected Shutdown 88
Imprecision 83
Failure to Charge 80
Break 75
Computer Hardware 73
Noise, Audible 67
Controller 62
Use of Device Problem 58
No Device Output 58
Monitor 52
Adverse Event Without Identified Device or Use Problem 52
Application Program Problem 48
Connector 48
Power Cord 43
Device Emits Odor 42
Power Switch 34
Physical Resistance / Sticking 34
Unintended Movement 30
Device Sensing Problem 27
Thermal Decomposition of Device 27
Image Display Error / Artifact 22
Detector 21
Smoking 20
Sparking 20
Wireless Communication Problem 20
Improper Device Output 18
Failure to Calibrate 17
Failure to Obtain Sample 16
Electrical Wire 16
Failure to Fire 15
Keyboard 15
Power Problem 14
Insufficient Information 13
Hinge 13
Bent 12
Data Problem 12
Device Damaged by Another Device 11
LED (Light Emitting Diode) 11
Display 11
Motherboard 10
Pin 10
Unstable 10
Arcing 10
Naturally Worn 9
Fracture 9
Frame 9
Premature Discharge of Battery 9
Erratic or Intermittent Display 7
Battery Problem 7
Connection Problem 7
Emergency Stop Button Or Switch 7
Output Problem 6
Unintended Application Program Shut Down 6
Device Issue 6
Application Program Problem: Dose Calculation Error 6
Image Reversal 6
Spring 6
Screw 5
Material Frayed 5
Intermittent loss of power 5
Unintended Electrical Shock 4
Overheating of Device 4
Loss of Power 3
Loose or Intermittent Connection 3
Caster 3
Foot Switch 3
Motor 3
Fan 3
Handpiece 3
Component Missing 3
Material Twisted / Bent 3
Human-Device Interface Problem 2
Issue With Displayed Error Message 2
Defective Component 2
Total Device Problems 16080

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 GE OEC Medical Systems, Inc II Nov-07-2014
7 Medtronic Navigation, Inc. II Feb-28-2014
8 Medtronic Navigation, Inc.-Littleton II Jul-03-2019
9 Medtronic Navigation, Inc.-Littleton II Oct-25-2018
10 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
11 Medtronic Navigation, Inc.-Littleton II Jul-06-2016
12 Orthoscan, Inc. II Jan-09-2018

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