Guardian System 2 Controller software update addresses missing battery alerts
Turncare is issuing a software update to the Guardian System 2 Controller to correct a bug where low and terminal battery alerts did not display under certain conditions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a missing visual alert, an informational defect rather than a dangerous physical condition. The issue occurred only in non-therapy use scenarios, limiting practical impact.
Plain-English summary
Turncare, Inc. has issued a software update to the Guardian System 2 Controller (Model GS-2.5-C) to correct a display issue affecting battery status alerts.
The issue occurred in specific circumstances when the device was not running patient therapy: the low and terminal battery alerts would not display on the screen, leaving users without visual notification of the battery status.
Approximately 1,142 units of the affected controller model have been distributed nationwide in Texas, Illinois, Pennsylvania, Florida, and Connecticut.
The corrected software version (2.5.4-69 Fix) has been made available to address this issue.
The recalled product
- Product
- Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
- Manufacturer
- Turncare, Inc
- Category
- Medical Device
- Hazard
- missing-battery-alert
- software-defect
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: 2.5.4-69 (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
- 2449.01
Distribution
Distributed nationwide across the United States.
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