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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, communication, powered
Product CodeILQ
Regulation Number 890.3710
Device Class 2


Premarket Reviews
ManufacturerDecision
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 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 136 136
No Audible Alarm 17 17
Defective Alarm 8 8
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
Adverse Event Without Identified Device or Use Problem 2 2
Activation Problem 2 2
Temperature Problem 2 2
Device Inoperable 2 2
Computer Software Problem 2 2
Defective Device 2 2
Insufficient Information 2 2
Wireless Communication Problem 2 2
Application Program Problem 2 2
Activation, Positioning or Separation Problem 2 2
Human-Device Interface Problem 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Discharge of Battery 1 1
Loose or Intermittent Connection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Misassembled During Installation 1 1
Alarm Not Visible 1 1
Protective Measures Problem 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Device Stops Intermittently 1 1
Overheating of Device 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Inadequate User Interface 1 1
Application Program Version or Upgrade Problem 1 1
Output Problem 1 1
Break 1 1
Failure To Adhere Or Bond 1 1
Unexpected Shutdown 1 1
Delayed Alarm 1 1
Device Difficult to Setup or Prepare 1 1
False Alarm 1 1
Device Difficult to Program or Calibrate 1 1
Labelling, Instructions for Use or Training Problem 1 1
Installation-Related Problem 1 1
Material Separation 1 1
Activation Failure 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 151 151
No Known Impact Or Consequence To Patient 11 11
Fall 10 10
Insufficient Information 6 6
Death 5 5
No Information 5 5
Head Injury 3 3
Superficial (First Degree) Burn 2 2
Stroke/CVA 2 2
No Code Available 2 2
Cardiac Arrest 2 2
No Consequences Or Impact To Patient 2 2
Complaint, Ill-Defined 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Burning Sensation 1 1
Laceration(s) 1 1
Therapeutic Effects, Unexpected 1 1
Hemorrhage/Bleeding 1 1
Loss of consciousness 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
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