Guardian System 2 Controller Software Battery Alert Display Issue
Turncare is recalling Guardian System 2 Controllers due to a software issue where low and terminal battery alerts do not display on the screen in certain circumstances when the device is not running patient therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 illnesses or injuries. The hazard is a battery alert display issue that could theoretically affect device use, but the source explicitly states only a software display problem with no patient harm reported, qualifying it as Moderate per the rubric.
Plain-English summary
Turncare, Inc. is recalling Guardian System 2 Controller devices (Model GS-2.5-C, Software Version 2.5.4-59) due to a software issue affecting battery alert displays. The recalled units were distributed nationwide in Texas, Illinois, Pennsylvania, Florida, and Connecticut.
The issue: Low and terminal battery alerts do not display on the screen to the user in specific circumstances when the device is not running patient therapy. This means users may not receive timely notification that the battery is running low or has reached a critical level, potentially affecting device functionality.
The recall affects 1,081 units of the Guardian System 2 Controller. Affected serial numbers are listed in the recall notice. Users should contact Turncare, Inc. for further instructions regarding this software issue.
For more information, users should visit the FDA's recall database or contact Turncare directly.
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
- Affected units
- 1,081
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
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