# FDA recall Z-0294-2024

> **Philips North America Llc** · Class II · device recall initiated 2023-10-09.

## Product

Brilliance CT Big Bore Oncology with software version V4.8.0.10421  Model:728243    CT scanner and simulator designed for radiation oncology and therapy.

## Reason for recall

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen.   For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

## Distribution

Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan

## Key facts

- **Recall number:** Z-0294-2024
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-09
- **Report date:** 2023-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2024

## Citation

> AI Analytics. FDA recall Z-0294-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0294-2024. Source: US FDA. Licensed CC0.

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