—#199549

Product

EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

FDA product code: DSJ — Alarm, Blood-Pressure
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K190624
Affected lot / code info: UDI: (01)00884838091412 Software Version A.00.02 and A.00.01

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Philips issued Urgent Field Safety Notice Letter on 3/3/23. Letter states reason for recall, health risk and action to take: 1. Identify the last calibration date of the device and review your hospital maintenance plan. Determine if your device has E01 End Tidal CO2 and has not been calibrated within one year of the production calibration. If needed adjust the maintenance plan and incorporate the calibration of your affected device. a. The device should not be used until the calibration or maintenance plan has been reviewed. b. The calibration date can be accessed via the following steps on the device: Settings > Admin > Diagnostics > Page 2 of Diagnostics > Maintenance > 129 > CO2 Test. The image below shows the example of the screen to see the last calibration date of your device: 2. Review this URGENT Field Safety Notice in its entirety and pass this notice to all those who need to be aware within your organization or to any organizations where the potentially affected devices have been transferred. (If appropriate). 3. Complete and return attached form to Philips promptly to confirm receipt of the URGENT Field Safety Notice Letter, understanding of the issue, and required actions to be taken. 4. Actions planned by Philips Hospital Patient Monitoring to correct the problem A Philips representative will reach out to you to arrange a software upgrade to your monitor(s). Philips will start to schedule the upgrade upon formal release of the field action, which is planned for a six month implementation timeline. If you need any further information or support concerning this issue, please contact your local Philips representative

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom

Timeline

Recall initiated: 2023-03-06
Posted by FDA: 2023-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.