FDA-Device2021-12-01Class II

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

Philips Healthcare
Hazard

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.

Sold states
US Nationwide distribution
Affected count
226 units
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2022

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