Recall Z-0734-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Healthcare
Azurion systems with software release R2.0.x
| Date | May 26, 2021 |
| Status | Completed |
| Reason | In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 8, 2022. Philips Field Service Engineers will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information, contact your local Philips representative: 1-800-722-9377. |
| Quantity | 69 systems |
| 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 |