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)
FDA Recall Z-1968-2025 · Posted 2025-06-12
Recalling FirmTurncare, Inc
Recall StatusOpen, Classified
Product CodeFNM
Date Initiated2023-08-10
Product Quantity1142 units
Reason for Recall
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.
Firm Action
Between November 2023 and January 2024 software updates to resolve the issue were performed by TurnCare on affected units. Successful update of the software was verified on each affected controller.
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.