Philips Healthcare Recall 89742
Description: Azurion systems with software release R2.0.x
Philips Healthcare Recall 89742 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0734-2022 |
| Event ID | 89742 |
| Event Description | Azurion systems with software release R2.0.x |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 69 systems |
| Recall 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. |
| Device Classification | 20220330 |
| Device Code Info | Model(s) Azurion R2.1 |
| Center Classification Date | 20220323 |
| Recall Initiation Date | 20210526 |
| Recalling Firm | Philips Healthcare |
| Initial Notification | Letter |
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