| Date Initiated by Firm |
March 06, 2023 |
| Date Posted |
May 26, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1645-2023 |
| Recall Event ID |
92063 |
| 510(K)Number |
K190624
|
| Product Classification |
Alarm, blood-pressure - Product Code DSJ
|
| Product |
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01
Product Number: 863380 |
| Code Information |
UDI: (01)00884838091412
Software Version A.00.02 and A.00.01 |
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
| For Additional Information Contact |
Philips Customer Services Worldwide
800-722-9377
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 |
1421 units US; 3 units OUS |
| Distribution |
Nationwide
Foreign:
Belgium
Brazil
Canada
Denmark
Germany
Guam
Hong Kong
Indonesia
Italy
Norway
Poland
Singapore
Sweden
Switzerland
United Kingdom
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = DSJ and Original Applicant = Philips Medizin Systeme Boeblingen GmbH
|
