# FDA recall Z-2174-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-03-30.

## Product

Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system

## Reason for recall

The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore.  This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.

## Distribution

Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.

## Key facts

- **Recall number:** Z-2174-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-30
- **Report date:** 2018-06-20
- **Termination date:** 2020-04-14

- **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-2174-2018

## Citation

> AI Analytics. FDA recall Z-2174-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2174-2018. Source: US FDA. Licensed CC0.

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