Philips SureSigns VS3 Monitor Recall Due to Software Defect
Philips is recalling SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to alarm for high pulse rates, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling 21,857 units of the SureSigns VS3 NBP, SpO2, Temp monitor (Product Number 863073). The recall is due to a system software defect that inhibits the monitor's ability to measure, display, and alarm for pulse rates above 240 beats per minute.
The affected devices were distributed worldwide, including the United States, Puerto Rico, and numerous international locations. The recall includes all serial numbers for the specified product number.
Healthcare facilities and users should contact Philips North America, LLC for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 21,857
Distribution
Part of a larger recall action
This product is one of 8 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Philips North America, LLC
See all →- HighPhilips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- ModeratePhilips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall
FDA (Devices) · 2026-07-01
- ModeratePhilips Telemetry Monitor 5500 Device Reset Risk Recall
FDA (Devices) · 2026-07-01
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25