FDA Device recall Z-2655-2023
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Produc…
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Produc… by Philips North America, citing A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2655-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-31 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
Reason
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Identifiers
| code_info | UDI-DI: 00884838075900; Serial Numbers: CN82203600 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2655-2023%22
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