IntelliVue Patient Monitor MX100 — Class II medical device recall Z-0861-2026
Ongoing recall by Philips North America Llc, reported 2025-12-10, distributed nationwide. Potential issue where the IntelliVue monitors did not alarm.
| Recall number | Z-0861-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2025-10-31 |
| Classified | 2025-12-02 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 1,913,441 units |
| UPC / GTIN / UDI-DI | 00884838082595 |
Product
IntelliVue Patient Monitor MX100. Product Number: 867033.
Reason for recall
Potential issue where the IntelliVue monitors did not 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-0861-2026. 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.