ClearanceBrief
Recall Z-0841-2025 ยท DWJ System, Thermal Regulating

Augustine Temperature Management, LLC

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

DateJan 10, 2025 (initiated Mar 14, 2022)
StatusCompleted
ReasonHotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Root causeDevice Design
ActionAugustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.
Quantity77 units
DistributionWorldwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.