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Recall Observatory FDA recall evidence

Device product

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.

Z-0701-2025

December 04, 2024

Class II

Product summary

Firm
Augustine Temperature Management, LLC
Event
Event 95703
Status
Ongoing
Classification
Class II
Quantity
1776 units
Official record key
device-enforcement:Z-0701-2025

Official wording

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".

Code information: 1) UDI-DI 00850011479025, Serial Numbers: 20080060-24060065; 2) UDI/DI 00850011479292, Serial Numbers: 20080060-24060065; 3) UDI-DI 00850011479308, Serial Numbers: 20080060-24060065

Distribution pattern: US and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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".