Philips Azurion systems with software releases 2.1(L1) recall: Software Issue
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Why was Philips Azurion systems with software releases 2.1(L1) recalled?
3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
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?
Azurion 2.1(L1) and 2.1(L2)
- Product
- Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
- Recalling firm
- Philips Healthcare
- Quantity
- 226 units
- Distribution
- US Nationwide distribution
- Recall date
- December 1, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)