Augustine Temperature Management Controllers May Fail Startup Self-Test
Augustine Surgical's veterinary temperature management controllers may experience a power-on self-test error during startup. Approximately 1,113 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: This is an FDA Class II medical device recall of a temperature management controller used in veterinary patient care. The power-on self-test error represents a functional defect in a device whose proper operation is critical for patient safety, constituting a risk-of-harm product with no reported injuries.
Plain-English summary
Augustine Surgical Inc. is recalling its HOT DOG temperature management controllers (models WC77V, WC77V-DEMO, and WC77V-R) used with warming blankets and mattresses in veterinary medical applications. Approximately 1,113 units have been distributed worldwide.
The controllers may experience a power-on self-test error code, designated 'EA POST,' during the startup sequence. This is a Class II recall, indicating a potential product safety concern.
The affected devices are identified by specific serial numbers spanning manufacturing periods from 2008 through 2024. Check the FDA recall notification with your device serial number to determine whether your unit is affected.
The recalled product
- Product
- Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
- Manufacturer
- Augustine Temperature Management, LLC
- Hazard
- startup-error
- temperature-control-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 00850011479254
- Serial Numbers: 20080090
- 20080091
- 20080092
- 20080093
- 20080094
- 20080095
- 20080097
- 20080098
- 20080099
- 20080100
- 20080102
- 20080103
- 20090000
- 20090001
- 20090002
- 20090003
- 20090004
- 20090005
- 20090006
Distribution
Distribution scope not specified by the agency.
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