Recall Z-0839-2025 ยท DWJ System, Thermal Regulating
Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
| Date | Jan 10, 2025 (initiated Mar 14, 2022) |
| Status | Completed |
| Reason | HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST". |
| Root cause | Device Design |
| Action | Augustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented. |
| Quantity | 17 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |