Azurion systems with software release R2.0.x recall: Software Issue
Azurion systems with software release R2.0.x
Why was Azurion systems with software release R2.0.x recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model(s) Azurion R2.1
- Product
- Azurion systems with software release R2.0.x
- Recalling firm
- Philips Healthcare
- Quantity
- 69 systems
- Distribution
- US Nationwide Distribution
- Recall date
- March 30, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)