IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software… — Class II medical device recall Z-0020-2025
Ongoing recall by Philips North America Llc, reported 2024-10-16. Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at th
| Recall number | Z-0020-2025 |
|---|---|
| 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 | 2023-06-14 |
| Classified | 2024-10-04 |
| Reported by FDA | 2024-10-16 |
| Countries outside the US | DE, DK, FR, GB, JP |
| Quantity | 153 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838038769, 00884838038776, 00884838038783 |
| Serial numbers | DE7580BB1Y, DE7580BB1Z, DE7580BB20, DE7580BB21, DE7580BB22, DE7580BB23, DE7580BB24, DE7580BB25, DE7580BBBA, DE7580BBUE, DE7580BBUK, DE7580BBUL, DE7580BBUY, DE7580BBUZ, DE7580BBV0, DE7580BBV1, DE7580BBVC, DE7580BBVD, DE7580BBVE, DE7580BBVF, DE7580BBVU, DE7580BBVV, DE7580BBVY, DE7580BBW9, DE7580BBWA and 128 more |
Product
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Reason for recall
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
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-0020-2025. 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.