Philips recalls Azurion systems with software release R1.x due to a defect causing incorrect patient type selection during studies, potentially affecting dose control. Affected units may need correction.
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 is recalling Azurion medical imaging systems with software release R1.x because a software defect causes the system to change patient types without warning during studies. This could lead to incorrect radiation dosing, which might affect patient safety.
The software defect causes the system to change the patient type to an incorrect value when starting a study. This changes the radiation dose settings without user notification, which could lead to improper radiation exposure for patients.
Medical facilities using Philips Azurion systems with software release R1.x are most at risk. Patients undergoing imaging studies with these systems could be affected if the patient type is misconfigured.
Check for Philips Azurion systems with software release R1.x. The software version is listed in the system's settings or documentation.
Look for the software version in the system settings or documentation to confirm if it is R1.x.
The software defect causes the system to change patient types without warning during studies, which could affect radiation dose settings.
Incorrect patient type selection may lead to improper radiation dose settings, potentially affecting patient safety.
Check your software version and contact Philips if it is R1.x to determine next steps.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0886-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0886-2022 from Philips. 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.
