Company: Turncare, Inc
Date of Enforcement Report: 6/12/2025
Class: II
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)
Recall Number:
Z-1967-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Turncare, Inc
VOLUME:
1081 units
DISTRIBUTION:
US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
