Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
computer, diagnostic, pre-programmed, single-function
Product Code
DXG
Regulation Number
870.1435
Device Class
2
Premarket Reviews
Manufacturer
Decision
DIRECTED SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
2
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
ICU MEDICAL
SUBSTANTIALLY EQUIVALENT
1
PULSION MEDICAL SYSTEMS SE
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
81
81
2020
49
49
2021
29
29
2022
44
44
2023
12
12
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Measurement
139
139
Incorrect, Inadequate or Imprecise Result or Readings
95
95
Smoking
13
13
Device Displays Incorrect Message
10
10
Break
9
9
Output Problem
8
8
Leak/Splash
7
7
Operating System Becomes Nonfunctional
7
7
Temperature Problem
7
7
Therapeutic or Diagnostic Output Failure
6
6
High Test Results
6
6
Inaccurate Information
5
5
Sparking
5
5
Electrical Power Problem
5
5
Fire
3
3
Battery Problem
3
3
Device Alarm System
3
3
Application Program Freezes, Becomes Nonfunctional
3
3
Display or Visual Feedback Problem
3
3
Low Readings
2
2
Ambient Temperature Problem
2
2
High Readings
2
2
Output below Specifications
2
2
Fluid/Blood Leak
2
2
Low Test Results
2
2
Intermittent Communication Failure
2
2
Material Fragmentation
2
2
Unable to Obtain Readings
2
2
Defective Device
2
2
No Display/Image
2
2
Power Problem
1
1
Overheating of Device
1
1
Inappropriate or Unexpected Reset
1
1
Increase in Pressure
1
1
Excessive Heating
1
1
Failure to Advance
1
1
Loss of Power
1
1
Noise, Audible
1
1
Misassembly by Users
1
1
Data Problem
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Energy Output Problem
1
1
Failure to Transmit Record
1
1
Thermal Decomposition of Device
1
1
Excessive Cooling
1
1
Material Separation
1
1
Unexpected Shutdown
1
1
Device Emits Odor
1
1
Pressure Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
119
119
No Clinical Signs, Symptoms or Conditions
99
99
No Known Impact Or Consequence To Patient
78
78
No Patient Involvement
15
15
Superficial (First Degree) Burn
2
2
Insufficient Information
2
2
High Blood Pressure/ Hypertension
1
1
Stroke/CVA
1
1
No Code Available
1
1
No Information
1
2
Alteration In Body Temperature
1
1
Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GETINGE US SALES LLC
II
Jul-25-2019
2
ICU Medical, Inc.
II
Jan-14-2021
3
ICU Medical, Inc.
II
May-07-2020
4
Lidco Ltd
II
Dec-30-2020
-
-