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 Initiated
- December 4, 2024
- Posted
- December 18, 2024
- Recall Number
- Z-0700-2025
- Quantity
- 135 units
- Firm Location
- Minnetonka, MN
Reason for Recall
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".
Distribution
US and Canada
Lot / Code Info
1) UDI-DI 00850011479018, Serial Numbers: 20080004-23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080004-23060141
Root Cause
Device Design
Action Taken
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, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.