Z-1318-2019Class II

SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP...

Name: Z-1318-2019 SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP...
Creator: Philips North America, LLC
Published: 2019-04-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-04-19 / Open, Classified / root cause: software

FDA source

Philips North America, LLC began a recall of SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature) on 2019-04-19. FDA classified it as Class II and gives the reason as "System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1318-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-04-19
Posted: 2019-05-13
Recalling firm: Philips North America LLC
Product: SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
Action: On April 19, 2019 Philips Healthcare issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. Actions to be taken by customer: Upon receipt of this notification, promptly perform the software upgrade to each of your SureSigns VS3/VS4 monitors, as called out in the attached Pulse Rate Software-Installation Instructions. It details how to obtain and install the system software update. It also provides instructions on how to export the file that is created during software installation and instructions where to email the file back to Philips. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.
Quantity in commerce: 518
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, 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.
Product codes and lots: Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1318-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1318-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1319-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1320-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1321-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1322-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1323-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13
Z-1324-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-13

Product code MHX

K163649Class IISureSigns VS3; SureSigns VS4Philips Medical Systems / cleared 2017-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)