EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359

FDA device recall Z-1644-2023 · posted 2023-05-26 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

Action taken

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

Root cause

Software design

Status

Open, Classified

Product code

DSJ

Quantity affected

64 units US; 20 units OUS

Distribution

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

Date initiated

2023-03-06

Date posted

2023-05-26

Location

Cambridge, MA