Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and...
Augustine Temperature Management, LLC began a recall of Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses on . FDA classified it as Class II and gives the reason as "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"". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0702-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Augustine Temperature Management, LLC
- Product
- Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
- Product code
- DWJ System, Thermal Regulating
- 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".
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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: [email protected] or by telephone, 952-465-3500, fax, 952-465-3501, 8AM - 5PM Central time.
- Quantity in commerce
- 116 units
- Distribution
- US and Canada
- Product codes and lots
- UDI-DI 00850011479582, Serial Numbers: 22120000-24030030
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0700-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0701-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0702-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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