Recall Z-1968-2025 ยท FNM Mattress, Air Flotation, Alternating Pressure
Turncare, Inc
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)
| Date | Jun 12, 2025 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Between November 2023 and January 2024 software updates to resolve the issue were performed by TurnCare on affected units. Successful update of the software was verified on each affected controller. |
| Quantity | 1142 units |
| Distribution | US Nationwide distribution in the states of Texas, Illinois, Pennsylvania, Florida, Connecticut. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.