Azurion systems with software release R1.x recall: Software Issue
Azurion systems with software release R1.x
Why was Azurion systems with software release R1.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?
The recall is ongoing. Follow the firm and FDA 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?
software release R1.x
- Product
- Azurion systems with software release R1.x
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 722 systems
- Distribution
- US Nationwide and Worldwide Distribution
- Recall date
- May 11, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)