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)
Reported: June 18, 2025 Initiated: November 1, 2023 #Z-1967-2025
Product Description
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.
Details
- Recalling Firm
- Turncare, Inc
- Units Affected
- 1081 units
- Distribution
- US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
- Location
- Pompton Plains, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Turncare, Inc. Units affected: 1081 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1967-2025.
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