# FDA recall Z-1396-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-02-21.

## Product

Brilliance 64 with 4.1.7 XX026 software version model number 728231    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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

## Reason for recall

Surview scan with tube current lower than 30 mA is unable to be initialized.

## Distribution

Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland

## Key facts

- **Recall number:** Z-1396-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-21
- **Report date:** 2018-04-25
- **Termination date:** 2020-04-10

- **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-1396-2018

## Citation

> AI Analytics. FDA recall Z-1396-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1396-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*