Recall – Software bug results in changed patient setting

Company: Philips Healthcare
Date of Enforcement Report: 3/30/2022
Class II

PRODUCT

Azurion systems with software release R2.0.x

Recall Number:

Z-0734-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Philips Healthcare on 5/26/2021. FDA Mandated.

VOLUME OF PRODUCT IN COMMERCE

69 systems

DISTRIBUTION

U.S. Nationwide

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