Azurion systems with software release R1.x
- Recall Initiated
- May 26, 2021
- Posted
- May 3, 2022
- Recall Number
- Z-0886-2022
- Quantity
- 722 systems
Reason for Recall
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.
Distribution
US Nationwide and Worldwide Distribution
Lot / Code Info
software release R1.x
Root Cause
Software design
Action Taken
Philips notified customers of the issue via Electronic Product Radiation Defect notification letter dated March 4, 2022. The letter identified the affected product, problem and actions to be taken. Customers were informed that they will be contacted by a Philips Field Service Engineers to schedule the software update at no cost. For questions contact your local Philips representative: 1-800-722-9377.