Augustine HotDog Patient Warming Temperature Controller May Display Power-on Self-Test Error
Augustine Temperature Management is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers for a power-on self-test error code EA POST.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Temperature management controllers are risk-of-harm medical devices. Although no illnesses or injuries are reported, a power-on self-test error could affect device functionality and patient safety. Per the rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
Augustine Temperature Management, LLC is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers (Models WC77, WC77D, and WC77R) distributed worldwide.
The temperature controllers may experience a power-on self-test error code 'EA POST' when powered on. The FDA classified this as a Class II recall.
The controllers are used in conjunction with warming blankets and mattresses for patient temperature management. Specific serial numbers for each model variant have been identified in the recall.
Consumers who own affected devices should contact Augustine Temperature Management, LLC for further instructions and guidance.
The recalled product
- Product
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
- Manufacturer
- Augustine Temperature Management, LLC
- Hazard
- self-test-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) UDI-DI 00850011479025
- Serial Numbers: 23070025
- 23070046
- 23110068
- 23110069
- 23110070
- 23060075
- 23110107
- 23120116
- 20100003
- 24040009
- 24040010
- 24040011
- 24040012
- 24080052
- 24080053
- 24080054
- 24010010
- 24010045
- 24070081
Distribution
Distribution scope not specified by the agency.
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