# FDA recall Z-0734-2022

> **Philips Healthcare** · Class II · device recall initiated 2021-05-26.

## Product

Azurion systems with software release R2.0.x

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0734-2022
- **Recalling firm:** Philips Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-05-26
- **Report date:** 2022-03-30

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0734-2022

## Citation

> AI Analytics. FDA recall Z-0734-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0734-2022. Source: US FDA. Licensed CC0.

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