# FDA recall Z-0238-2022

> **Philips Healthcare** · Class II · device recall initiated 2021-09-24.

## Product

Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)

## Reason for recall

3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or  landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction.  Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at  0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.

## Distribution

US Nationwide distribution

## Key facts

- **Recall number:** Z-0238-2022
- **Recalling firm:** Philips Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-24
- **Report date:** 2021-12-01

- **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-0238-2022

## Citation

> AI Analytics. FDA recall Z-0238-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0238-2022. Source: US FDA. Licensed CC0.

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