Augustine Surgical temperature management controllers may experience power-on self-test error
Augustine Surgical temperature management controllers (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code. Seventeen units have been recalled 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 for patient temperature management. The reported power-on self-test error indicates potential device malfunction. No injuries or illnesses are reported. As a Class II device with potential failure but no documented harm, it meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Augustine Surgical Inc. has recalled temperature management controllers, Models WC71, WC77, and MP Model 2083516. These devices are used with warming blankets and mattresses to manage patient body temperature. Seventeen units have been recalled and distributed worldwide.
The affected controllers may experience a power-on self-test error code labeled 'EA POST' when powered on. This error may indicate a device malfunction. No details regarding clinical consequences or recommended user actions are provided in the source.
The recalled product
- 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.
- Manufacturer
- Augustine Temperature Management, LLC
- Category
- Medical Device — Patient Warming
- Hazard
- device-malfunction
- 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 (19)
- 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
Distribution scope not specified by the agency.
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