Philips recalls Azurion systems with specific software versions due to potential 3D X-ray scan errors. Affected units may produce inaccurate scans if detector orientation is not precisely aligned.
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.
Philips is recalling Azurion medical imaging systems with software versions 2.1(L1) and 2.1(L2) because they can create 3D scans with detector angles slightly off the required 0 or +/-90 degrees. This could lead to inaccurate scans if the detector isn't perfectly aligned during scans.
The software allows 3D scans with detector angles deviating up to 3 degrees from the exact portrait or landscape orientation. Scans with angles more than 1 degree off cannot be properly reconstructed by the software, potentially causing inaccurate medical images.
Medical facilities using Philips Azurion systems with software releases 2.1(L1) or 2.1(L2) are likely affected. Patients undergoing scans with these systems may be at risk of inaccurate results.
Check if your Philips Azurion system has software versions 2.1(L1) or 2.1(L2). These versions were sold with the Azurion system starting in 2021.
Verify your system's software version to see if it is 2.1(L1) or 2.1(L2).
Philips discovered that these software versions allow 3D scans with detector angles deviating up to 3 degrees from the required portrait or landscape orientation, which can cause inaccurate scans.
Check your system's software version. If it is 2.1(L1) or 2.1(L2), you may need to update to a newer version to ensure accurate scans.
The recall addresses potential inaccuracies in 3D scans, which could affect medical diagnosis. However, the software issue does not pose a direct safety risk to patients.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0238-2022 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0238-2022 from Philips Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
