Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
- Recall Initiated
- July 13, 2018
- Recall Number
- Z-2893-2018
- Quantity
- VM 96,324 Units; VS 110,424 Units; VSV 691 Units
- Firm Location
- Andover, MA
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, Tanzania, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Zambia and Zimbabwe.
Lot / Code Info
UDI# VS3 (863069): 00884838000094, (863070): 00884838000100, (863071): 00884838000117, (863072): 00884838000124, (863073): 00884838000131, (863074): 00884838000148
Root Cause
Labeling design
Action Taken
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