# FDA recall Z-1392-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2018-02-15.

## Product

Ingenuity TF PET/CT, Model No. 882442    Product Usage:  The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.

## Reason for recall

Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.

## Distribution

Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.

## Key facts

- **Recall number:** Z-1392-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-15
- **Report date:** 2018-04-25
- **Termination date:** 2019-11-21

- **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-1392-2018

## Citation

> AI Analytics. FDA recall Z-1392-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1392-2018. Source: US FDA. Licensed CC0.

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