SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Check against the official notice below — it lists the full affected range.
Philips North America, LLC is recalling 12,543 units of the SureSigns VS3 NBP monitor (Product Number 863071) distributed worldwide, including across the US and Puerto Rico. The monitor is designed to measure physiological parameters including blood pressure, oxygen saturation, and temperature. The devices have a software defect that prevents the monitor from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
The affected devices can be identified by serial numbers included with the UDIs (01)00884838028890(21) and (01)00884838087075(21). The recall does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Reason for recall: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. Distribution: Worldwide distribution. US Nationwide including Puerto Rico, Andorra, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Dominican Republic, Egypt, France, French Guiana, French Polynesia, Germany, Gibraltar, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jor Quantity: 12543 Lot/code info: Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.