Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses
FDA device recall Z-0702-2025 · posted 2024-12-18 · Open, Classified
Recall details
- Recalling firm
- Augustine Temperature Management, LLC
- Reason for recall
- Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
- Action taken
- Augustine Temperature Management issued a Field Notification to its consignees on 12/04/2024 via email. The notice explained the issue, potential risk, and advised that there is an update to the User and Technical Manual to further clarify existing instructions for the device. If the device was further distributed, those distributing the device were directed to notify those to whom the device was distributed. Consignees are expected to respond via email. An optional power board update is available. For questions or concerns, contact: customercare@augsurg.com or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DWJ
- Quantity affected
- 116 units
- Distribution
- US and Canada
- Date initiated
- 2024-12-04
- Date posted
- 2024-12-18
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HotDog Temperature Management System (K220941) | Augustine Temperature Management | 2022-09-23 |
| HotDog Temperature Management Controller (K201779) | Augustine Temperature Management | 2020-09-11 |