Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version
FDA device recall Z-1967-2025 · posted 2025-06-12 · Open, Classified
Recall details
- Recalling firm
- Turncare, Inc
- 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.
- Action taken
- Between June 2023 and November 2023 software updates to resolve the issue were performed by TurnCare on affected units. The 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. Successful update of the software was verified on each affected controller.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- FNM
- Quantity affected
- 1081 units
- Distribution
- US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut
- Date initiated
- 2023-11-01
- Date posted
- 2025-06-12
- Location
- Pompton Plains, NJ
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