Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling SureSigns VS4 monitors because software prevents the device from measuring 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 involves a medical device with a functional defect that could lead to missed alarms for critical physiological parameters, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling the SureSigns VS4 NBP, SpO2 monitor (Product Number 863283). The recall involves 61,522 units distributed worldwide, including the United States and Puerto Rico.
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. This limitation may prevent the device from providing accurate physiological monitoring for patients with very high heart rates.
Healthcare facilities and users should contact Philips North America, LLC for instructions on how to resolve the software issue. The recall covers all serial numbers for the affected product.
The recalled product
- Product
- SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 61,522
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