01

Dec

2021

Recall – 3D reconstruction software orientation deviates from spec

recall, softwareerror

0

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

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