Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azurion systems with software release R2.0.x Recalled by Philips Healthcare Due to In the Azurion system, the user can add...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare directly.
Affected Products
Azurion systems with software release R2.0.x
Quantity: 69 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare
Philips Healthcare has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report