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
system, communication, powered
Product Code
ILQ
Regulation Number
890.3710
Device Class
2
Premarket Reviews
Manufacturer
Decision
IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
12
12
2016
4
4
2017
7
7
2018
7
7
2019
2
2
2020
2
2
2021
5
5
2022
27
27
2023
74
74
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
86
86
No Audible Alarm
17
17
Defective Alarm
6
6
Use of Device Problem
6
6
Communication or Transmission Problem
6
6
Device Operates Differently Than Expected
6
6
Device Displays Incorrect Message
3
3
Application Program Problem
2
2
Device Inoperable
2
2
Defective Device
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Temperature Problem
2
2
Computer Software Problem
2
2
Insufficient Information
2
2
Wireless Communication Problem
2
2
Activation Problem
2
2
Activation, Positioning or Separation Problem
2
2
Misassembled During Installation
1
1
Unexpected Shutdown
1
1
Activation Failure
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Nonstandard Device
1
1
Overheating of Device
1
1
Device Difficult to Setup or Prepare
1
1
Device Difficult to Program or Calibrate
1
1
Product Quality Problem
1
1
Material Separation
1
1
Device Stops Intermittently
1
1
Delayed Alarm
1
1
False Alarm
1
1
Alarm Not Visible
1
1
Failure To Adhere Or Bond
1
1
Premature Discharge of Battery
1
1
Break
1
1
Therapeutic or Diagnostic Output Failure
1
1
Output Problem
1
1
Protective Measures Problem
1
1
Human-Device Interface Problem
1
1
Inadequate User Interface
1
1
Installation-Related Problem
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Defective Component
1
1
Application Program Version or Upgrade Problem
1
1
Connection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
101
101
No Known Impact Or Consequence To Patient
11
11
Fall
9
9
Insufficient Information
6
6
No Information
5
5
Death
5
5
No Code Available
2
2
Stroke/CVA
2
2
No Consequences Or Impact To Patient
2
2
Head Injury
2
2
Cardiac Arrest
2
2
Hemorrhage/Bleeding
1
1
Loss of consciousness
1
1
Superficial (First Degree) Burn
1
1
Therapeutic Effects, Unexpected
1
1
Complaint, Ill-Defined
1
1
Burning Sensation
1
1
Laceration(s)
1
1
Bone Fracture(s)
1
1
Abrasion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Jun-30-2022
2
Baxter Healthcare Corporation
II
May-13-2022
3
Dynavox Systems Llc
II
Apr-03-2018
4
Forbes Rehab Services Inc
II
Dec-28-2021
5
Hill-Rom Inc.
II
Dec-20-2021
6
Lifeline Systems Company
II
Apr-06-2018
7
Lifeline Systems, Incorporated
II
Oct-01-2015
8
Lifeline Systems, Incorporated
II
Jul-06-2015
9
Medminder Systems, Inc.
II
Jun-09-2022
10
Philips Lifeline Inc
II
Nov-25-2009
11
Rauland-Borg Corp
II
Sep-17-2013
12
Stanley Security Solutions Inc
II
Mar-20-2017
13
Tobii Assistive Technology, Inc.
II
Feb-01-2013
14
Tobii Assistive Technology, Inc.
II
Jun-29-2011
15
Tobii Dynavox Llc
II
Apr-18-2023
-
-