Recall Z-1968-2025— Turncare, Inc
Class II · Ongoing
Class II FDA medical device recall by Turncare, Inc, initiated 2023-08-10. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: A 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..
- Recalling firm
- Turncare, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-10
- Firm location
- Pompton Plains, NJ, United States
Product description
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)
Reason for recall
A 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.