# FDA recall Z-0511-2018

> **Philips Medical Systems (Cleveland) Inc** · Class II · device recall initiated 2017-12-15.

## Product

BrightView XCT Model 882482    Product Usage:  BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

## Reason for recall

During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-0511-2018
- **Recalling firm:** Philips Medical Systems (Cleveland) Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-15
- **Report date:** 2018-02-14
- **Termination date:** 2020-04-10

- **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-0511-2018

## Citation

> AI Analytics. FDA recall Z-0511-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0511-2018. Source: US FDA. Licensed CC0.

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