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

Recall date

September 24, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0238-2022

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

US Nationwide distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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