Class 2 Device Recall Philips SureSigns VM 3/4/6/8 Patient Monitors

• Date Initiated by Firm: July 13, 2018
• Create Date: August 22, 2018
• Recall Status: Open, Classified
• Recall Number: Z-2895-2018
• Recall Event ID: 80645
• 510(K)Number: K080495 K123900
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063; 863064; 863065; 863066; 863068; 863077; 863085; 863086; 863317; 863287; 863288; 863289; ; The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature
• Code Information: UDI#'s VM3 (863077): 00884838028791 VM4 (863063): 00884838000032, (863085): 00884838028807 VM6 (863064): 00884838000049, (863065): 00884838000056, (863086): 00884838028814 VM8 (863066): 00884838000063, (863068): 00884838000087, (863087): 00884838028821, (863088): 00884838028838, (863317): 00884838050464
• Recalling Firm/ Manufacturer: Philips Electronics North America Corporation; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Customer Service; 800-722-9377
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS