Recall Z-1324-2019 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America, LLC
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
| Date | Apr 19, 2019 |
| Status | Open, Classified |
| Reason | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Root 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 |
| Quantity | 366 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163649 | SureSigns VS3; SureSigns VS4 Philips Medical Systems, Mar 31, 2017 |