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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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 96 96
No Audible Alarm 17 17
Use of Device Problem 6 6
Communication or Transmission Problem 6 6
Device Operates Differently Than Expected 6 6
Defective Alarm 6 6
Device Displays Incorrect Message 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Activation, Positioning or Separation Problem 2 2
Activation Problem 2 2
Device Inoperable 2 2
Computer Software Problem 2 2
Defective Device 2 2
Insufficient Information 2 2
Temperature Problem 2 2
Application Program Problem 2 2
Wireless Communication Problem 2 2
Delayed Alarm 1 1
Unexpected Shutdown 1 1
Protective Measures Problem 1 1
Material Separation 1 1
Installation-Related Problem 1 1
Alarm Not Visible 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Output Problem 1 1
Nonstandard Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate User Interface 1 1
Overheating of Device 1 1
Break 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Failure To Adhere Or Bond 1 1
Material Integrity Problem 1 1
Device Stops Intermittently 1 1
Defective Component 1 1
Improper or Incorrect Procedure or Method 1 1
False Alarm 1 1
Misassembled During Installation 1 1
Human-Device Interface Problem 1 1
Application Program Version or Upgrade Problem 1 1
Device Difficult to Setup or Prepare 1 1
Therapeutic or Diagnostic Output Failure 1 1
Connection Problem 1 1
Activation Failure 1 1
Premature Discharge of Battery 1 1
Device Difficult to Program or Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
No Known Impact Or Consequence To Patient 11 11
Fall 9 9
Insufficient Information 6 6
No Information 5 5
Death 5 5
Cardiac Arrest 2 2
Stroke/CVA 2 2
Head Injury 2 2
No Code Available 2 2
No Consequences Or Impact To Patient 2 2
Complaint, Ill-Defined 1 1
Loss of consciousness 1 1
Superficial (First Degree) Burn 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Therapeutic Effects, Unexpected 1 1
Burning Sensation 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
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