Philips Healthcare Recall 89750
Description: Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Philips Healthcare Recall 89750 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0737-2022 |
| Event ID | 89750 |
| Event Description | Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 42 Systems |
| Recall 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. |
| Device Classification | 20220413 |
| Device Code Info | Azurion R2.1 |
| Center Classification Date | 20220405 |
| Recall Initiation Date | 20220202 |
| Recalling Firm | Philips Healthcare |
| Initial Notification | Letter |
| Similar To |