# FDA recall Z-2896-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2018-07-13.

## 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.

## 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

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, Ta

## Key facts

- **Recall number:** Z-2896-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-07-13
- **Report date:** 2018-08-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2896-2018

## Citation

> AI Analytics. FDA recall Z-2896-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2896-2018. Source: US FDA. Licensed CC0.

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