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Turncare, Inc recalls Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Vers
Recalled June 18, 2025 · FDA recall Z-1967-2025 · Turncare
Hazard
A software 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. · FDA Class II
Units
1081 units
Sold at
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
Description
A software 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.
Product
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Manufacturer(s)
Turncare, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →