Guardian System 2 Controller units recalled for battery alert display defect
Turncare has recalled certain Guardian 2 System controllers because a software issue prevented "low" and "terminal" battery alerts from displaying on the screen in specific circumstances when the device was 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 missing user alert in specific circumstances (device not running therapy), making it a labeling/information defect rather than a direct safety failure. The source text states no adverse health consequences are documented.
Plain-English summary
Turncare, Inc. is recalling certain Guardian System 2 Controller units (Model GS-2.5-C, Software Version 2.5.4-69) distributed nationwide in Texas, Illinois, Pennsylvania, Florida, and Connecticut.
A software defect caused "low" and "terminal" battery alerts to fail to display on the device screen in specific circumstances when the device was not running patient therapy. This could prevent users from being alerted to critical battery status conditions.
Users of affected units should contact Turncare, Inc. for information about obtaining the software update and verifying their device's serial number against the recall list. The FDA is classifying this as a Class II recall.
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
- Affected units
- 1,142
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
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