# FDA recall Z-0309-2019

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2017-06-07.

## Product

Ingenuity Core (Model No. 728321), Software version 4.1.6    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 analysts and display equipment, patient and equipment supports, components, and accessories.

## Reason for recall

It was reported that scanners running certain software versions provide confusing information in the "Impressions"  section of the Calcium Score report. The generated report provides multiple  analyses of the amount of plaque detected, as if they all apply to the patient at  the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0309-2019
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-07
- **Report date:** 2018-11-07
- **Termination date:** 2019-07-03

- **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-0309-2019

## Citation

> AI Analytics. FDA recall Z-0309-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0309-2019. Source: US FDA. Licensed CC0.

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