Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling 366 SureSigns VS4 monitors because software 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 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 366 units of the SureSigns VS4 Government Bundle (Product Number 863286). These devices are used to monitor patient 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 could result in the device failing to provide 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, with specific UDI prefixes (01)00884838028890(21) and (01)00884838087075(21) followed by the serial number. Healthcare providers and facilities should contact Philips North America for instructions on how to address the software issue.
The recalled product
- Product
- SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 366
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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