# FDA recall Z-0522-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2017-11-01.

## Product

Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

## Reason for recall

One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

## Distribution

One domestic and 1 foreign consignee ( Spain)

## Key facts

- **Recall number:** Z-0522-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-01
- **Report date:** 2018-02-14
- **Termination date:** 2018-08-14

- **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-0522-2018

## Citation

> AI Analytics. FDA recall Z-0522-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0522-2018. Source: US FDA. Licensed CC0.

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