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.
Recall
- Recall Number
- Z-0700-2025
- Event Number
- 95703
- Firm
- Augustine Temperature Management, LLC
- FEI Number
- 3005857264
- Product Code
- DWJ
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 4, 2024
- Posted
- December 18, 2024
- Address
- 15305 Minnetonka Blvd, Minnetonka, MN, 55345-1512
Description
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.
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".
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: [email protected] or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
US and Canada
135 units