EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A — Class II medical device recall Z-1644-2023
Ongoing recall by Philips North America Llc, reported 2023-06-07, distributed nationwide. EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an ina
| Recall number | Z-1644-2023 |
|---|---|
| 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 | 2023-03-06 |
| Classified | 2023-05-26 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, CH, DE, DK, GB, HK, ID, IT, NO, PL, SE, SG |
| UPC / GTIN / UDI-DI | 00884838075900 |
Product
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Reason for recall
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
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-1644-2023. 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.