Philips SureSigns VS3 Monitor Software Defect Recalled
Philips is recalling 518 SureSigns VS3 monitors because a software defect prevents the device from measuring 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 is classified as FDA Class II. The hazard involves a failure to alarm for high pulse rates, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Philips North America, LLC is recalling 518 units of the SureSigns VS3 NBP Temp monitor (Product Number 863070). 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 affected product number.
Healthcare facilities should contact Philips North America, LLC for instructions on how to resolve the software issue. The source text does not specify a specific action for consumers, as these are medical devices used in professional settings.
The recalled product
- Product
- SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 518
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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