Home / Recalls / Philips Electronics North America Corporation / Z-2896-2018

Z-2896-2018 Class II Ongoing

Recalled by Philips Electronics North America Corporation — Andover, MA

FDA device recall Z-2896-2018 was initiated by Philips Electronics North America Corporation on Jul 13, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: VM 96,324 Units; VS 110,424 Units; VSV 691 Units.

Recall Details

Product Type: Devices
Report Date: Aug 29, 2018
Initiation Date: Jul 13, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: VM 96,324 Units; VS 110,424 Units; VSV 691 Units

Product Description

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.

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.

Distribution Pattern

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.

Code Information

UDI# VS2 (863079): 00884838009639, (863080): 00884838009646, (863081): 00884838009653, (863082): 00884838009660

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2896-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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