[pending] Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-
Pending LLM rewrite. Source: FDA_DEVICE Z-1967-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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)
- Manufacturer
- Turncare, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Catalog Number: GS-2.5-C
- Software Version: 2.5.4-59 (Fix)
- UDI-DI: (01)00860001236453
- Serial Numbers: 2007.01
- 2037.01
- 2070.01
- 2074.01
- 2160.01
- 2186.01
- 2191.01
- 2197.01
- 2200.01
- 2203.01
- 2236.01
- 2259.01
- 2286.01
- 2299.01
- 2301.01
- 2303.01
- 2384.01
Distribution
Distributed nationwide across the United States.
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