Philips North America, LLC: SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Is my product affected?

SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

• UPC 00884838028890
• UPC 00884838087075

Check against the official notice below — it lists the full affected range.

What happened

Philips North America is recalling 1,397 SureSigns VS3 NBP monitors (Product Number 863069) used to measure patients' blood pressure, oxygen saturation, and temperature. The monitors have a software defect that prevents them from measuring, displaying, or sounding an alarm when a patient's pulse rate exceeds 240 beats per minute. The affected devices have been distributed worldwide to numerous countries including the United States, Puerto Rico, Canada, and many others.

The recalled monitors can be identified by their serial numbers and Universal Device Identifiers (UDIs) listed as (01)00884838028890(21) and (01)00884838087075(21) followed by the device's 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.

Hazard

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

Details from the source

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: 1397 Lot/code info: Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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