Philips Healthcare: Medical Device Recall in 2021 - (Recall #: Z-0238-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 24, 2021

Date Posted: December 1, 2021

Recall Number: Z-0238-2022

Event ID: 89020

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.

Status: Ongoing

Product Quantity: 226 units

Code Information:

Azurion 2.1(L1) and 2.1(L2)

Distribution Pattern:

US Nationwide distribution

Voluntary or Mandated:

FDA Mandated