Philips IntelliVue Measurement Module X1 Model: M3001A — Class II medical device recall Z-0853-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-03-02, distributed nationwide. The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicate
| Recall number | Z-0853-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-01-04 |
| Classified | 2016-02-23 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2021-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, EE, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MA, MY, NL, NO, OM, PH, PK, PL, QA, RO, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Quantity | 13,300 |
| Model numbers | M3001A |
Product
Philips IntelliVue Measurement Module X1 Model: M3001A
Reason for recall
The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
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-0853-2016. 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.