Z-2896-2018Class II

Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs...

Name: Z-2896-2018 Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs...
Creator: Philips Electronics North America Corporation
Published: 2018-07-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-07-13 / Open, Classified / root cause: labeling and UDI

FDA source

Philips Electronics North America Corporation began a recall of Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever... on 2018-07-13. FDA classified it as Class II and gives the reason as "Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2896-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-13
Posted: 2018-08-22
Recalling firm: Philips North America LLC
Product: Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. The Sure Signs VS2 vital signs monitor is for the monitoring, recording and alarming of multiple parameters of adult, pediatric and neonates in healthcare environments. Additionally, this monitor is intended for transport situations within the healthcare facility.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On July 13, 2018, the firm issued an "URGENT-Medical Device Correction" letter dated July 10, 2018, to affected customers to advise them that that monitors with batteries that have exceeded their specified replacement interval may overheat or ignite. The firm issued a Service Guide addendum included with the letter, which contains information to assist with managing the battery and its replacement. Customers were advised to do the following: Upon receipt of this notification, carefully read the enclosed SureSigns Addendum to the Service Guide. VS Series Customers -Addendum to the Service Guide: 453564807541 VM Series Customers -Addendum to the Service Guide: 453564807551 VSV Customers- Addendum to the Service Guide: 453564815301 Promptly perform the Battery Maintenance that is called out in the Addendum for each of your affected Philips SureSigns VS & VM Monitors and View Station (VSV) by determining if the Battery Information Screen indicates if the battery cycle count exceeds the limit of 300 cycles, or the battery is older than three (3) years. If so, the battery needs to be replaced. The replacement battery can be ordered using the standard Philips replacement processes. Details on how to replace the battery can be found in the Philips SureSigns VS & VM Monitors and View Station (VSV) Service Guide. Review this information with all staff members who are responsible for device management of the Philips SureSigns VS & VM Monitors and View Station (VSV). Please store the below Service Guide Addendum with your Philips SureSigns VS & VM Monitors and View Station (VSV) Service Guide documentation. VS Series Customers -Addendum to the Service Guide: 453564807541 VM Series Customers -Addendum to the Service Guide: 453564807551 VSV Customers- Addendum to the Service Guide: 453564815301 Complete and return the response card provided. In addition to providing the Service Guide Addendum and this notice, Philips plans to release a customer ins
Quantity in commerce: VM 96,324 Units; VS 110,424 Units; VSV 691 Units
Distribution: Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, France, French Guiana, French Polynesia, Finland, Guadeloupe, Germany, Ghana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Lybia, Macao, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Zambia and Zimbabwe.
Product codes and lots: UDI# VS2 (863079): 00884838009639, (863080): 00884838009646, (863081): 00884838009653, (863082): 00884838009660

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2896-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2892-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22
Z-2893-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22
Z-2894-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22
Z-2895-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22
Z-2896-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22

Product code MHX

K090483Class IISursigns Vs2 Vital Signs Monitor, Suresigns Vs3 Vital Signs Monitor, Suresigns Vm Series Patient MonitorsPhilips Medical Systems / cleared 2009-03-20

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)