Product Safety Recalls

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Philips Healthcare Recall 89742

Description: Azurion systems with software release R2.0.x

Philips Healthcare Recall 89742 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-0734-2022
Event ID89742
Event DescriptionAzurion systems with software release R2.0.x
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity69 systems
Recall ReasonIn 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 Classification20220330
Device Code InfoModel(s) Azurion R2.1
Center Classification Date20220323
Recall Initiation Date20210526
Recalling FirmPhilips Healthcare
Initial Notification Letter
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