Company: Philips Healthcare
Date of Enforcement Report: 12/1/2021
Class II
PRODUCT
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Recall Number: Z-0238-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Healthcare on 9/24/2021. FDA Mandated
VOLUME OF PRODUCT IN COMMERCE
226 units
DISTRIBUTION
U.S. Nationwide