Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77
FDA device recall Z-0840-2025 · posted 2025-01-10 · Completed
Recall details
- Recalling firm
- Augustine Temperature Management, LLC
- Reason for recall
- HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
- Action taken
- Augustine 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.
- Root cause
- Device Design
- Status
- Completed
- Product code
- DWJ
- Quantity affected
- 817 units
- Distribution
- Worldwide
- Date initiated
- 2022-03-14
- Date posted
- 2025-01-10
- Location
- Minnetonka, MN
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