# FDA recall Z-0840-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-01-03.

## Product

Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243     Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

## Reason for recall

Software issues including:  Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan;  Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card;  Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed;  Software errors that may result in partial set of images or inability to generate CT images.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-0840-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-03
- **Report date:** 2018-03-14
- **Termination date:** 2019-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cleveland, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0840-2018

## Citation

> AI Analytics. FDA recall Z-0840-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0840-2018. Source: US FDA. Licensed CC0.

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