Recall Z-0737-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Healthcare
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
| Date | Feb 2, 2022 |
| Status | Terminated |
| Reason | Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, the following on-screen message is displayed to the user in the Philips StentBoost Live application: "Press the cine pedal until the acquisition stops". However, due to the incorrect configuration of the EPX database, the acquisition does not stop after 40 images, but instead it continues as long as the pedal is pressed. |
| 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 2, 2022. Philips 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 | 42 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 |