IntelliVue MX40 Patient Monitor — Class II medical device recall Z-2142-2018
Terminated recall by Philips Electronics North America Corporation, reported 2018-06-20, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Five warning statements are missing from the instructions for use.
| Recall number | Z-2142-2018 |
|---|---|
| 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 | 2018-04-30 |
| Classified | 2018-06-11 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-10-04 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CL, CN, CZ, DK, EE, ES, FI, FR, GB, GH, GR, HK, HR, IE, IL, IN, IS, IT, JP, KR, LB, LV, MX, MY, NL, NO, NZ, PH, PL, PT, QA, RU, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Quantity | 7,178 |
| Model numbers | 865351 |
Product
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Reason for recall
Five warning statements are missing from the instructions for use.
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-2142-2018. 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.