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Recall Observatory FDA recall evidence

Device product

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.

Z-0839-2025

March 14, 2022

Class II

Product summary

Firm
Augustine Temperature Management, LLC
Event
Event 95913
Status
Completed
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-0839-2025

Official wording

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".

Code information: 1) UDI-DI 00850011479018, Serial Numbers: 23060144, 22030085, 22030087, 22030088, 23060138, 23060139, 22030075, 22030076, 22030077, 22030079, 22030080, 22030081, 22030082, 22030083, 22030084, 23060141; 2) UDI-DI 00850011479285, Serial Numbers: 20080002

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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".