SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. 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 3,177 units of the SureSigns VS3 NBP patient monitor (Product Number 863072) due to a software defect. The monitor is designed to measure and display physiological parameters including blood pressure, oxygen saturation, and temperature. The recalled units have a system software problem that prevents the monitor from measuring, displaying, or alarming when a patient's pulse rate exceeds 240 beats per minute, which could pose a risk to patients requiring monitoring at high heart rates.
The recalled monitors have been distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries internationally. The recall affects all units with serial numbers matching the specified UDIs ending in (21)00884838028890 or (21)00884838087075 followed by the serial number. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
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: 3177 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.