Lower risk Medical device recall · FDA · Published May 26, 2021

Philips Azurion Systems with R2.0.x Software: Incorrect Patient Type Risk

Philips Healthcare recalls Azurion systems with software release R2.0.x due to a defect causing incorrect patient type selection during studies, potentially affecting dose control. Affected units include Azurion R2.1 models.

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

🇺🇸 FDA recall #Z-0734-2022Medical device Philips Healthcare ›

Lower-risk recall

In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Philips Healthcare is recalling Azurion systems with software release R2.0.x because a software defect causes the system to change patient types during studies without warning. This could lead to incorrect radiation doses being delivered to patients, which may affect treatment safety. Read more at govinfonow.com/recall/62480-philips-azurion-systems-with-r2-0-x-software-incorrect-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/62480-philips-azurion-systems-with-r2-0-x-software-incorrect-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0734-2022

Cite this page

“Philips Azurion Systems with R2.0.x Software: Incorrect Patient Type Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62480-philips-azurion-systems-with-r2-0-x-software-incorrect-patient. Based on FDA recall #Z-0734-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2022%22&limit=1).

The FDA announced on 2021-05-26 that Philips Healthcare is recalling Azurion systems with software release R2.0.x due to a software defect that may inadvertently change the patient type during procedures. This error alters dose control technique factors without notifying the user. The agency issued recall number Z-0734-2022 for the Class II device.

How to tell if you have it

Brand: Philips Healthcare
Product: Azurion systems with software release R2.0.x
Model: Azurion R2.1
Quantity: 69 systems

The hazard

According to the FDA, when a user initiates a study by pressing Start Procedure, the Patient Type changes inadvertently to one different than selected. Because patient type is involved in dose control, this incorrect selection changes the technique factors used by the system without notification to the user.

Context

GovInfoNow's records show Philips Healthcare has had six other recalls since 2018-06-11. Other recent recalls of similar products include Philips Incisive CT Software 5.0 Recall (2023-08-02), Philips StentBoost Live R2.0 (2022-02-02), and Philips Azurion Systems with 2.1(L1) and 2.1(L2) Software Recalled for 3D Scan Errors (2021-09-24). Additional recent recalls of similar products include Philips Azurion System Software R3.1 May Cause Imaging Loss (2025-12-12), Philips Azurion Systems R3.0 Software Issues (2025-12-08), and Philips Azurion 5 M12 System Software Recalls (2026-01-26).

How to tell if you have this one

Check if your Philips Azurion system has software release R2.0.x, specifically model Azurion R2.1. The recall applies to systems sold with this software version.

Brand
Philips Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your Azurion system's software version to see if it is R2.0.x (specifically R2.1).

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 10 months after the firm started it.

May 26, 2021Firm started the recall
Mar 23, 2022FDA classified it Class II
Mar 30, 2022Published in FDA’s Enforcement Report

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

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Keep exploring

More Philips Healthcare recalls

Link to this recall

<a href="https://govinfonow.com/recall/62480-philips-azurion-systems-with-r2-0-x-software-incorrect-patient">Philips Azurion Systems with R2.0.x Software: Incorrect Patient Type Risk (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-0734-2022 (May 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0734-2022 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.