SureSigns VS3 NBP Temp, Product Number 863070. 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 518 units of the SureSigns VS3 NBP Temp monitor (Product Number 863070), which is used to monitor patients' blood pressure, oxygen levels, and temperature. The monitors have a software defect that prevents them from measuring, displaying, or alarming when a patient's pulse rate exceeds 240 beats per minute. The affected devices have been distributed worldwide, including across the United States, Puerto Rico, and numerous international locations.
The recall affects all serial numbers of this product model with the specified Universal Device Identifiers (UDIs): (01)00884838028890(21) and (01)00884838087075(21). The source document does not specify a remedy or instructions for what affected consumers should do.
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: 518 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.