# FDA recall Z-0016-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2017-01-18.

## Product

Philips Healthcare Ingenuity Core  X-Ray, Tomography, Computed    These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

## Reason for recall

During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.

## Distribution

USA (nationwide) Distribution

## Key facts

- **Recall number:** Z-0016-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-01-18
- **Report date:** 2017-10-25
- **Termination date:** 2020-02-26

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0016-2018

## Citation

> AI Analytics. FDA recall Z-0016-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0016-2018. Source: US FDA. Licensed CC0.

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