Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device system, environmental control, powered
Product CodeIQA
Regulation Number 890.3725
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2022 2 2
2023 18 26
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 14 22
Labelling, Instructions for Use or Training Problem 2 2
Activation Failure 2 2
Defective Alarm 2 2
Device Fell 1 1
Failure of Device to Self-Test 1 1
Noise, Audible 1 1
Operating System Becomes Nonfunctional 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 29
Head Injury 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Securitas Healthcare LLC II Jul-23-2024
2 Securitas Healthcare LLC II Jul-23-2024
3 Securitas Healthcare LLC II May-31-2024
4 Securitas Healthcare LLC II Nov-03-2023
5 Securitas Healthcare LLC II Mar-14-2023
6 Stanley Security Solutions Inc II Jan-14-2022
7 Stanley Security Solutions Inc II Jul-19-2019
-
-