# FDA recall Z-1142-2019

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-07-03.

## Product

Brilliance 16 Air, 728246    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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories

## Reason for recall

Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.

## Distribution

Distributed only to China and UK.

## Key facts

- **Recall number:** Z-1142-2019
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-03
- **Report date:** 2019-04-24
- **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-1142-2019

## Citation

> AI Analytics. FDA recall Z-1142-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1142-2019. Source: US FDA. Licensed CC0.

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