SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. 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 21,857 units of the SureSigns VS3 NBP monitoring device (Product Number 863073) that was distributed worldwide, including throughout the United States, Puerto Rico, and numerous international locations. The device is used to monitor patients' blood pressure, oxygen saturation, and temperature. The recall was initiated because system software in the monitor prevents it from measuring, displaying, and alarming for pulse rates above 240 beats per minute.
The affected devices include all serial numbers with the Universal Device Identifiers (01)00884838028890(21) and (01)00884838087075(21) followed by the serial number. The source document does not specify a remedy or recommended course of action for consumers who possess this product.
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: 21857 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.