Z-1644-2023Class II

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

Name: Z-1644-2023 EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Creator: Philips North America Llc
Published: 2023-03-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-03-06 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 on 2023-03-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1644-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-06
Posted: 2023-05-26
Recalling firm: Philips North America LLC
Product: EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Product code: DSJ Alarm, Blood-Pressure
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.
Root cause tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 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
Product codes and lots: UDI: (01)00884838075900 Software Version A.00.02 and A.00.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1644-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1644-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26
Z-1645-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26

Product code DSJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)