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Recall Observatory FDA recall evidence

Device product

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.

Z-0702-2025

December 04, 2024

Class II

Product summary

Firm
Augustine Temperature Management, LLC
Event
Event 95703
Status
Ongoing
Classification
Class II
Quantity
116 units
Official record key
device-enforcement:Z-0702-2025

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: UDI-DI 00850011479582, Serial Numbers: 22120000-24030030

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".