FDA recall Z-1967-2025

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)

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-11-01

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-1967-2025