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EarlyVue VS30 Vitals monitor with Software Versions A.00.02… recallZ-1645-2023 · Philips North America Llc · initiated Mar 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-1645-2023
Status
Open, Classified
Initiated by the company
Mar 6, 2023
Posted by the FDA
May 26, 2023
Recalling firm
Philips North America Llc
Quantity
1421 units US; 3 units OUS
Product code
DSJ
FDA submissions
K190624
Distribution
Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom

Product description

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

Code information (models, lots, serial numbers)

UDI: (01)00884838091412 Software Version A.00.02 and A.00.01

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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