PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Medical Device Recall in 2022 - (Recall #: Z-0886-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Azurion systems with software release R1.x

Product Classification:

Class II

Date Initiated: May 26, 2021

Date Posted: May 11, 2022

Recall Number: Z-0886-2022

Event ID: 89964

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 722 systems

Code Information:

software release R1.x

Distribution Pattern:

US Nationwide and Worldwide Distribution

Voluntary or Mandated:

FDA Mandated