SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. 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 12,719 units of the SureSigns VS3 NBP patient monitoring system worldwide due to a software defect. The system fails to measure, display, or alarm for pulse rates above 240 beats per minute, potentially preventing clinicians from detecting dangerously high heart rates in patients.
The affected devices were distributed globally, including throughout the United States, Puerto Rico, and numerous international locations. All serial numbers of this model are included in the recall. The source does not specify what consumers or healthcare facilities 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: 12719 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.