Recall Z-2205-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagn
| Date | Jul 16, 2019 |
| Status | Terminated |
| Reason | The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment. |
| Root cause | Software design |
| Action | Philips issued notification on July 16, 2019 advising users of the problem, health risk and action to take: If the start-up screen shows software version R1 .2, your system has the affected release and FC072200430 should be implemented on your system. If the start-up screen shows software version R1.2.1, your system has the latest system software release and is not affected by this issue. Philips will also be contacting customers with affected systems directly. Until Philips corrects your Philips Azurion system. At least once every 50 days, briefly disconnect the Azurion system from the mains |
| Quantity | 834 |
| Distribution | US Nationwide Distribution Foreign: Canada Argentina AUSTRALIA Austria Azerbaijan Bahrain Bangladesh Belgium Bosnia and Herzegovina Brazil Bulgaria Chile Colombia CROATIA Denmark ECUADOR Egypt Finland France Germany Greece Hong Kong India Indonesia Ireland Israel Italie Italy Japan Jordan Kazakhsta |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172822 | Azurion series R1.2 Philips Medical Systems Nederland B.V., Nov 22, 2017 |