Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling 3,177 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 is classified as FDA Class II. The hazard involves a risk-of-harm product (medical monitor) where the failure to alarm for high pulse rates poses a potential risk to patient safety, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling 3,177 units of the SureSigns VS3 NBP, SpO2, Rec monitor (Product Number 863072). The device is used to monitor physiological parameters, including non-invasive blood pressure, oxygen saturation, and temperature.
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 data or necessary alerts for patients with extremely high heart rates.
The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous international locations. The recall includes all serial numbers. Healthcare facilities and users should contact Philips for further instructions on how to address the software issue.
The recalled product
- Product
- SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 3,177
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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