Philips SureSigns VS3 Monitor Recall for High Pulse Rate Measurement Failure
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high pulse rates, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 12,543 units of the SureSigns VS3 NBP, SpO2 monitor (Product Number 863071). 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 this specific product number.
Healthcare facilities and users should stop using the affected monitors and contact Philips for further instructions regarding the software defect.
The recalled product
- Product
- SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 12,543
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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