CLASS II ONGOING Device recall · Reported 22 May 2019 · FDA Enforcement Report

SureSigns VS3 NBP, Product Number recalled by Philips North America

Philips North America is recalling SureSigns VS3 NBP, Product Number 863069, distributed nationwide in the US. The recall was initiated on 19 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.

Quantity recalled1397

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1317-2019
FDA event ID: 82684
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Apr 2019
FDA classified: 13 May 2019
Reported: 22 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

19 Apr 2019	Recall initiated by company
13 May 2019	Classified by FDA	+24 days
22 May 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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, Jordan, Kenya, Korea Republic, Kosovo, Kuwait, Latvia, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Martinique, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Portugal, Qatar, Reunion, Romania, Rwanda, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Kingdom, United Arab Emirates,Venezuela, Vietnam, and Zimbabwe.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 82684

This product is part of a recall event; the main page for the event is SureSigns VS3 NBP Temp, Product Number recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
22 May 2019	CLASS II	SureSigns VS3 NBP Temp, Product Number recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
22 May 2019	CLASS II	SureSigns VS3 NBP, SpO2, Temp, Product Number recalled	Philips North America	Device Malfunction	Nationwide
22 May 2019	CLASS II	SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number recalled	Philips North America	Device Malfunction	Nationwide
22 May 2019	CLASS II	SureSigns VS3 NBP, SpO2, Product Number recalled	Philips North America	Device Malfunction	Nationwide
22 May 2019	CLASS II	SureSigns VS4 Government Bundle, Product Number recalled	Philips North America	Device Malfunction	Nationwide
22 May 2019	CLASS II	SureSigns VS3 NBP, SpO2, Rec, Product Number recalled	Philips North America	Device Malfunction	Nationwide
22 May 2019	CLASS II	SureSigns VS4 NBP, SpO2, Product Number recalled	Philips North America	Device Malfunction	Nationwide

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