SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
- Company
- Philips North America, Llc
- Recall Initiated
- April 19, 2019
- Recall Number
- Z-1319-2019
- Quantity
- 12543
- Firm Location
- Andover, MA
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.
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.
Lot / Code Info
Serial Numbers: All Including UDIs: (01)00884838028890(21) and (01)00884838087075(21) followed by serial number.
Root Cause
Software design
Action Taken
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.