Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Recall Z-0238-2022 · Posted None
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Recalling FirmPhilips Healthcare
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2021-09-24
Product Quantity226 units
Reason for Recall
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.
Firm Action
Philips will inform customers of the issue via an Electronic Product Radiation Correction notification. The letter identified the affected product, problem and actions to be taken. Philips Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your Philips representative at 1-800-722-9377.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Nationwide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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