IntelliVue Patient Monitor MX450 with L — Class II medical device recall Z-2509-2024
Ongoing recall by Philips North America Llc, reported 2024-08-14, distributed nationwide. Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Cha
| Recall number | Z-2509-2024 |
|---|---|
| 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 | 2024-06-28 |
| Classified | 2024-08-05 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BR, CA, CH, CL, CN, CO, DE, DK, ES, FR, GB, HK, ID, IN, IT, JP, KR, LK, NL, PT, SE, SG, TH, TW, VN, ZA |
| Quantity | 49 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838038769 |
| Model numbers | 866062 |
Product
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
Reason for recall
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
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-2509-2024. 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.