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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion systems with software release R1.x

Recalled May 11, 2022 · FDA recall Z-0886-2022 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V

Hazard
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. · FDA Class II
Units
722 systems
Sold at
US Nationwide and Worldwide Distribution

Description

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.

Product
Azurion systems with software release R1.x
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →