FDA recall Z-1968-2025

Turncare, Inc · Class II · device

Product

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)

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.

Distribution

US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut.

Key facts

Status
Ongoing
Initiation date
2023-08-10
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pompton Plains, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1968-2025