Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping — Class II medical device recall Z-0292-2017
Terminated recall by Philips Electronics North America Corporation, reported 2016-10-26, distributed nationwide. Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG
| Recall number | Z-0292-2017 |
|---|---|
| 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 | 2016-09-19 |
| Classified | 2016-10-20 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2018-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, AW, BE, BG, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GH, GR, HK, IE, IN, IQ, IS, IT, JP, KR, MX, MY, NL, NO, NZ, PH, PL, PT, SE, SG, SI, TH, TR, ZA |
| Quantity | 1,824 units |
| UPC / GTIN / UDI-DI | 00453564262511, 00453564615331 |
| Model numbers | 453564262491, 453564262511, 453564262531, 453564262551, 453564262571, 453564262591, 453564467761, 453564615311, 453564615331, 453564615351, 453564615371 |
Product
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide except for the USA SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Reason for recall
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
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-0292-2017. 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.