Class 2 Device Recall SureSigns VS3 NBP, SpO2, Temp

• Date Initiated by Firm: April 19, 2019
• Create Date: May 13, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1321-2019
• Recall Event ID: 82684
• 510(K)Number: K163649
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
• Code Information: Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
• FDA Determined Cause: Software design
• Action: On April 19, 2019 Philips Healthcare issued URGENT MEDICAL DEVICE CORRECTION notices to customers via courier service. Actions to be taken by customer: Upon receipt of this notification, promptly perform the software upgrade to each of your SureSigns VS3/VS4 monitors, as called out in the attached Pulse Rate Software-Installation Instructions. It details how to obtain and install the system software update. It also provides instructions on how to export the file that is created during software installation and instructions where to email the file back to Philips. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.
• Quantity in Commerce: 21857
• Distribution: Worldwide distribution. US Nationwide including Puerto Rico, Andorra, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Dominican Republic, Egypt, France, French Guiana, French Polynesia, Germany, Gibraltar, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea Republic, Kosovo, Kuwait, Latvia, Lebanon, Lesotho, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Martinique, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Portugal, Qatar, Reunion, Romania, Rwanda, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Kingdom, United Arab Emirates,Venezuela, Vietnam, 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