Philips North America, LLC SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Philips North America, LLC is recalling SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of pati due to System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Recommended Action
Per FDA guidance
On April 19, 2019 Philips Healthcare issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. Actions to be taken by customer: Upon receipt of this notification, promptly perform the software upgrade to each of your SureSigns VS3/VS4 monitors, as called out in the attached Pulse Rate Software-Installation Instructions. It details how to obtain and install the system software update. It also provides instructions on how to export the file that is created during software installation and instructions where to email the file back to Philips. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026