Turncare, Inc recalls Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Versio…

Recall date

August 10, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1968-2025

FDA classification

Class II

Brand / firm

Turncare, Inc

Sold / distributed

US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.

Why it was recalled

A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)