Lower risk Medical device recall · FDA · Published September 24, 2021

Philips Azurion Systems with 2.1(L1) and 2.1(L2) Software Recalled for 3D Scan Errors

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0238-2022Medical device Philips Healthcare ›

Lower-risk 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.

Take action

Contact the company

Recalling firmPhilips Healthcare3000 Minuteman Rd · Andover, MA 01810-1032

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61755-philips-azurion-systems-with-2-1-l1-and-2-1.

Source Summary by GovInfoNow · govinfonow.com/recall/61755-philips-azurion-systems-with-2-1-l1-and-2-1 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0238-2022

Cite this page

“Philips Azurion Systems with 2.1(L1) and 2.1(L2) Software Recalled for 3D Scan Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61755-philips-azurion-systems-with-2-1-l1-and-2-1. Based on FDA recall #Z-0238-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0238-2022%22&limit=1).

The FDA announced on 2021-09-24 that Philips Healthcare is recalling Philips Azurion systems with software releases 2.1(L1) and 2.1(L2). The hazard involves the 3D-RA reconstruction software allowing scans with deviating detector orientation that cannot be reconstructed.

How to tell if you have it

Brand: Philips Healthcare
Product: Philips Azurion systems
Software releases: 2.1(L1) and 2.1(L2)
Units affected: 226

The hazard

The 3D-RA reconstruction software allows creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation. Scans with a deviating detector orientation of more than 1.0 degree cannot be reconstructed with the 3D-RA reconstruction software.

Context

GovInfoNow's records show Philips Healthcare has 6 other recalls on record since 2018-06-11. Other recent recalls include Philips DigitalDiagnost C90 Recall (2021-09-22), Philips StentBoost Live R2.0 (2022-02-02), and Philips Incisive CT Software 5.0 Recall (2023-08-02). Similar recent recalls of Azurion systems include Philips Azurion System Software R3.1 May Cause Imaging Loss (2025-12-12) and Philips Azurion Systems R3.0 Software Issues: Risk of Image Loss and System Failures (2025-12-08).

How to tell if you have this one

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.

Brand
Philips Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version to see if it is 2.1(L1) or 2.1(L2).

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 24, 2021Firm started the recall
Nov 24, 2021FDA classified it Class II
Dec 1, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this software version?

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.

Are there any risks to patients?

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.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61755-philips-azurion-systems-with-2-1-l1-and-2-1">Philips Azurion Systems with 2.1(L1) and 2.1(L2) Software Recalled for 3D Scan Errors (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0238-2022 (September 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0238-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.