# FDA recall Z-0886-2022

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2021-05-26.

## Product

Azurion systems with software release R1.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 and Worldwide Distribution

## Key facts

- **Recall number:** Z-0886-2022
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-26
- **Report date:** 2022-05-11

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Best, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0886-2022

## Citation

> AI Analytics. FDA recall Z-0886-2022. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0886-2022. Source: US FDA. Licensed CC0.

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