Recall Z-0238-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Healthcare
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
| Date | Sep 24, 2021 |
| Status | Open, Classified |
| Reason | 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orienta |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips will inform customers of the issue via an Electronic Product Radiation Correction notification. The letter identified the affected product, problem and actions to be taken. Philips Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your Philips representative at 1-800-722-9377. |
| Quantity | 226 units |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |