# FDA recall Z-0331-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2017-11-08.

## Product

Philips Healthcare Brilliance iCT computed tomography x-ray system

## Reason for recall

There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs,  the part(s) will not be expelled, however, a noise may be heard coming from the gantry.

## Distribution

107 domestic accounts  15 US Govt accounts  682 Foreign Accounts  3 Mexico accounts  12 Canada accounts

## Key facts

- **Recall number:** Z-0331-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-08
- **Report date:** 2018-01-17
- **Termination date:** 2020-04-17

- **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-0331-2018

## Citation

> AI Analytics. FDA recall Z-0331-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0331-2018. Source: US FDA. Licensed CC0.

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