Recall Z-0734-2022— Philips Healthcare
Class II · Completed
Class II FDA medical device recall by Philips Healthcare, initiated 2021-05-26. It names one FDA 510(k) clearance: K200917. Product: Azurion systems with software release R2.0.x. 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..
- Recalling firm
- Philips Healthcare
- Classification
- Class II
- Status
- Completed
- Initiated
- 2021-05-26
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Azurion systems with software release R2.0.x
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.