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