FDA-Device2025-06-18Class II
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)
Turncare, Inc
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.
Sold states
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
Affected count
1081 units
Manufactured in
230 W Parkway Ste 6, Pompton Plains, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1967-2025Don't want to check this manually?
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