Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling SureSigns VS3 patient monitors because a software defect 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (patient monitor) where the failure to alarm for high pulse rates could lead to patient harm, though no specific injuries are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling 12,719 units of the SureSigns VS3 NBP, SpO2, Temp, Rec patient monitor (Product Number 863074). 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 in the United States, Puerto Rico, and numerous international locations. The recall includes all serial numbers for the affected product number.
Healthcare facilities and users should stop using the affected monitors and contact Philips for further instructions on corrective actions or replacements.
The recalled product
- Product
- SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 12,719
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.
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