Philips Healthcare recalls Azurion systems with software release R2.0.x

Recall date

May 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0734-2022

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

US Nationwide Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Azurion systems with software release R2.0.x