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Device
system, x-ray, mobile
Regulation Description
Mobile x-ray system.
Product Code
IZL
Regulation Number
892.1720
Device Class
2
Premarket Reviews
Manufacturer
Decision
Carestream Health Inc.
SUBSTANTIALLY EQUIVALENT
1
CARESTREAM HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
DEL MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
DRGEM CORPORATION
SUBSTANTIALLY EQUIVALENT
3
FUJIFILM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE
SUBSTANTIALLY EQUIVALENT
3
GENERAL ELECTRIC CO.
SUBSTANTIALLY EQUIVALENT
3
KONICA MINOLTA, INC.
SUBSTANTIALLY EQUIVALENT
2
MERIDIAN MEDICAL SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
1
Minxray Inc
SUBSTANTIALLY EQUIVALENT
2
OEHM UND REHBEIN GMBH
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
SUBSTANTIALLY EQUIVALENT
1
SAMSUNG ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
SAMSUNG ELECTRONICS CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SEDECAL SA
SUBSTANTIALLY EQUIVALENT
3
SIEMENS
SUBSTANTIALLY EQUIVALENT
1
SOLUTIONS FOR TOMORROW AB
SUBSTANTIALLY EQUIVALENT
1
SOURCE-RAY, INC.
SUBSTANTIALLY EQUIVALENT
1
THE KRETCHMER CORP.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2016
33
33
2017
35
35
2018
27
27
2019
40
40
2020
48
48
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
32
32
Unintended System Motion
20
20
Use of Device Problem
17
17
Break
13
13
Improper or Incorrect Procedure or Method
12
12
Smoking
11
11
Detachment of Device or Device Component
10
10
Adverse Event Without Identified Device or Use Problem
8
8
Device Operational Issue
7
7
No Display/Image
7
7
Fire
7
7
Device Component Or Accessory
7
7
Insufficient Information
7
7
Mechanical Problem
6
6
Device Operates Differently Than Expected
6
6
Screw
5
5
Device Handling Problem
5
5
Device Fell
5
5
Device Displays Incorrect Message
5
5
Image Display Error/Artifact
5
5
Unintended Collision
4
4
Self-Activation or Keying
4
4
Component Falling
4
4
Electrical /Electronic Property Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Device Emits Odor
4
4
Cable, Electrical
3
3
Device Slipped
3
3
Failure to Shut Off
3
3
Device Issue
3
3
Sparking
3
3
Thermal Decomposition of Device
3
3
Power Cord
3
3
Poor Quality Image
3
3
Battery Problem
3
3
Electrical Shorting
3
3
Device Inoperable
3
3
Material Integrity Problem
3
3
Misassembly During Maintenance/Repair
2
2
Arcing
2
2
Loose or Intermittent Connection
2
2
Battery
2
2
Plug
2
2
Collimator
2
2
Cover
2
2
Detachment Of Device Component
2
2
Screen
2
2
Computer Software Problem
2
2
Temperature Problem
2
2
Overheating of Device
2
2
Cap
2
2
Collapse
1
1
Crack
1
1
Bolt
1
1
Brake
1
1
Cord
1
1
Generator
1
1
Unintended Arm Motion
1
1
Bent
1
1
No Device Output
1
1
Migration or Expulsion of Device
1
1
Fracture
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loss of Power
1
1
Device Difficult to Setup or Prepare
1
1
Material Separation
1
1
Failure to Align
1
1
Defective Device
1
1
Human-Device Interface Problem
1
1
Output Problem
1
1
Device Dislodged or Dislocated
1
1
Appropriate Term/Code Not Available
1
1
Function Indicator Light
1
1
Wheel
1
1
Misassembly by Users
1
1
Washer
1
1
Noise, Audible
1
1
Wireless Communication Problem
1
1
Material Discolored
1
1
Material Frayed
1
1
Device Alarm System
1
1
Premature Discharge of Battery
1
1
Hinge
1
1
Pin
1
1
User Interface
1
1
Switches
1
1
Device Maintenance Issue
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Product Quality Problem
1
1
Material Rupture
1
1
Improper Device Output
1
1
Connection Problem
1
1
Loss of Data
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Difficult to Advance
1
1
Positioning Problem
1
1
Reset Problem
1
1
Emergency Button Or Switch
1
1
Motor Drive Unit
1
1
Data Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
66
66
No Consequences Or Impact To Patient
30
30
No Patient Involvement
16
16
Radiation Exposure, Unintended
11
11
Bone Fracture(s)
10
10
No Clinical Signs, Symptoms or Conditions
9
9
No Information
8
8
Death
6
6
Bruise/Contusion
5
5
No Code Available
4
4
Patient Problem/Medical Problem
4
4
Not Applicable
3
3
Pneumothorax
2
2
Unspecified Infection
2
2
Laceration(s)
2
2
Insufficient Information
2
2
Joint Dislocation
2
2
Hematoma
2
2
Swelling
1
1
Physical Entrapment
1
1
Fracture, Arm
1
1
Abrasion
1
1
Radiation Burn
1
1
Fall
1
1
Fatigue
1
1
Skin Tears
1
1
Unspecified Respiratory Problem
1
1
Unintended Radiation Exposure
1
1
Pain
1
1
Cardiac Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AGFA Healthcare Corp.
II
Mar-29-2017
2
Carestream Health Inc
II
Jun-19-2017
3
Carestream Health Inc
II
Feb-03-2017
4
Fujifilm Medical Systems U.S.A., Inc.
II
Aug-30-2019
5
Fujifilm Medical Systems U.S.A., Inc.
II
Mar-21-2019
6
GE Medical Systems, LLC
II
Feb-08-2016
7
NeuroLogica Corporation
II
May-30-2019
8
Philips Healthcare Inc.
II
Apr-04-2017
9
Sedecal S.A.
II
Mar-08-2016
10
Sedecal USA, Inc.
II
Jun-03-2016
11
Shimadzu Medical Systems
II
Dec-04-2020
12
Shimadzu Medical Systems Usa Com
II
Mar-21-2019
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