# FDA recall Z-0403-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2017-07-11.

## Product

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

## Reason for recall

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

## Distribution

Worldwide distribution, including US nationwide.

## Key facts

- **Recall number:** Z-0403-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-11
- **Report date:** 2018-01-31
- **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-0403-2018

## Citation

> AI Analytics. FDA recall Z-0403-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0403-2018. Source: US FDA. Licensed CC0.

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