IntelliVue MX40 Wearable Patient Monitor in use with the Philips… — Class II medical device recall Z-1746-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-06-18, distributed nationwide. IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming whe
| Recall number | Z-1746-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-05-22 |
| Classified | 2014-06-10 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2018-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BE, BG, BH, CA, CH, CL, CZ, DE, DK, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, LV, MX, MY, NL, NO, NZ, OM, PL, PT, QA, SA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 42,600 |
| Reason classes | software |
Product
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Reason for recall
IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
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-1746-2014. 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.