# FDA recall Z-0388-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2017-11-10.

## Product

Brilliance iCT    Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

## Reason for recall

Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

## Distribution

Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom.    4 in US, (1 military), 14 foreign accounts

## Key facts

- **Recall number:** Z-0388-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-10
- **Report date:** 2018-01-24
- **Termination date:** 2020-11-05

- **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-0388-2018

## Citation

> AI Analytics. FDA recall Z-0388-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0388-2018. Source: US FDA. Licensed CC0.

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