FDA Device recall Z-1645-2023
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380 by Philips North America, citing 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 ch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1645-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-06 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Reason
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.
Identifiers
| code_info | UDI: (01)00884838091412 Software Version A.00.02 and A.00.01 |
|---|
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-1645-2023%22
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