Recall Z-1967-2025 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: 2.5.4-59 (Fix)
| Date | Jun 12, 2025 (initiated Nov 1, 2023) |
| Status | Open, Classified |
| Reason | A software 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 June 2023 and November 2023 software updates to resolve the issue were performed by TurnCare on affected units. The 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. Successful update of the software was verified on each affected controller. |
| Quantity | 1081 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.