# FDA recall Z-0841-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-01-11.

## Product

IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

## Reason for recall

23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include:  "	Software errors that may result in CT spectral images misrepresentation or incorrect treatment;  "	Software errors that may result in partial set of images or inability to generate CT images.

## Distribution

Domestic and Foreign

## Key facts

- **Recall number:** Z-0841-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-11
- **Report date:** 2018-03-14
- **Termination date:** 2019-05-20

- **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-0841-2018

## Citation

> AI Analytics. FDA recall Z-0841-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0841-2018. Source: US FDA. Licensed CC0.

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