Augustine Temperature Management Controller Experiences Power-On Self-Test Failures
Augustine's HOT DOG temperature management controller (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code 'EA POST' that indicates a diagnostic failure. Approximately 2,271 units have been distributed worldwide.
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: FDA Class II medical device recall without reported injuries or hospitalizations. A power-on self-test failure on a temperature management controller represents a risk-of-harm to patient care in veterinary settings, though no adverse events have been documented.
Plain-English summary
The FDA has recalled Augustine Temperature Management, LLC's HOT DOG temperature management controller devices used in veterinary settings. The affected models include WC71, WC77, and Temperature Management Controller MP Model 2083516. These controllers are used with warming blankets and mattresses to manage patient temperature during procedures and recovery.
The recalled devices may experience a power-on self-test error code 'EA POST.' This error indicates a diagnostic failure in the device's built-in self-test system.
Approximately 2,271 units have been distributed worldwide. Veterinary facilities that have these devices should contact Augustine Temperature Management for further instructions regarding repair, replacement, or return. Specific serial numbers of affected devices are identified in the FDA recall notice.
The recalled product
- Product
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
- Manufacturer
- Augustine Temperature Management, LLC
- Hazard
- self-test-error
- equipment-malfunction
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 00850011479247
- Serial Numbers: 20090015
- 20090016
- 20090017
- 20090018
- 20090020
- 20090021
- 20090022
- 20090023
- 20090024
- 20090025
- 20090026
- 20090027
- 20090028
- 20090029
- 20090030
- 20090031
- 20090032
- 20090033
- 20090034
Distribution
Distribution scope not specified by the agency.
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