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.
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.
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.
The software defect causes the system to change the patient type setting to an incorrect value when starting a study. This change happens without user notification and affects the dose control process, which could result in improper radiation exposure levels for patients.
Healthcare facilities using Philips Azurion systems with software release R2.0.x (specifically Azurion R2.1 models) are affected. Medical staff and patients using these systems for imaging procedures are at risk of receiving incorrect radiation doses.
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.
Verify your Azurion system's software version to see if it is R2.0.x (specifically R2.1).
The recall applies to Philips Azurion systems with software release R2.0.x, specifically model Azurion R2.1. Check your software version to determine if you are affected.
The software defect can cause the system to change patient types during studies without warning, which may lead to incorrect radiation doses being delivered to patients. However, the recall does not specify a risk of serious injury.
The recall does not provide a remedy, so no specific action is required beyond checking your software version. If you are affected, contact Philips Healthcare for further guidance.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0734-2022 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0734-2022 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.
