SureSigns VS4 Government Bundle, Product Number 863286. 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 is recalling 366 units of the SureSigns VS4 Government Bundle (Product Number 863286), a patient monitoring system used to measure blood pressure, oxygen saturation, and temperature. The recalled monitors have a software defect that prevents them from measuring, displaying, and alarming for pulse rates above 240 beats per minute, which could fail to alert medical personnel to dangerously elevated heart rates in patients.
The affected monitors were distributed worldwide, including throughout the United States and Puerto Rico, as well as numerous international locations. The recall affects all serial numbers of this product, including those with the specified UDIs (01)00884838028890(21) and (01)00884838087075(21). The recall notice does not specify a remedy or corrective action 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: 366 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.