Recall Z-1645-2023 ยท DSJ Alarm, Blood-Pressure
Philips North America Llc
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
| Date | May 26, 2023 (initiated Mar 6, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 th |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190624 | EarlyVue VS30 Philips Medizin Systeme Boeblingen GmbH, Oct 27, 2019 |