Recall Z-0701-2025 ยท DWJ System, Thermal Regulating
Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
| Date | Dec 18, 2024 (initiated Dec 4, 2024) |
| Status | Open, Classified |
| Reason | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST". |
| Root cause | Device Design |
| Action | Augustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. If the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. An optional power board update is available. For questions or concerns, contact: customercare@augsurg.com or by telephone, 952-465-3 |
| Quantity | 1776 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |