InnerCool RTx Endovascular System — Class II medical device recall Z-0845-2014
Terminated recall by Philips Healthcare, reported 2014-02-05, distributed nationwide. Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low p
| Recall number | Z-0845-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare, San Diego, CA, United States |
| Recall initiated | 2014-01-13 |
| Classified | 2014-01-27 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2014-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, FR, NL, SE |
| Quantity | 50 |
| Model numbers | 861470 |
Product
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908
Reason for recall
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0845-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.