EarlyVue VS30 Vitals Monitor — Class II medical device recall Z-2654-2023
Ongoing recall by Philips North America Llc, reported 2023-10-11, distributed nationwide. A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits a
| Recall number | Z-2654-2023 |
|---|---|
| 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 | 2023-08-31 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR |
| Quantity | 13 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838091412 |
| Serial numbers | DE72400231, DE72400232, DE72400235, DE72400237, DE72400238, DE72400239, DE72400254, DE72401360, DE72401393, DE72409240, DE72409249, DE72409250 |
Product
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Reason for recall
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
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-2654-2023. 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.