Philips Healthcare Azurion systems with software release R2.0.x Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Azurion systems with software release R2.0.x
Brand
Philips Healthcare
Lot Codes / Batch Numbers
Model(s) Azurion R2.1
Products Sold
Model(s) Azurion R2.1
Philips Healthcare is recalling Azurion systems with software release R2.0.x due to 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 wh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026