# FDA recall Z-2523-2018

> **GE Healthcare, LLC** · Class II · device recall initiated 2016-09-16.

## Product

Brivo XR385, model 5215463, Digital Diagnostic Radiographic System

## Reason for recall

The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.

## Distribution

AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada.

## Key facts

- **Recall number:** Z-2523-2018
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-09-16
- **Report date:** 2018-08-01
- **Termination date:** 2018-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2018

## Citation

> AI Analytics. FDA recall Z-2523-2018. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-2523-2018. Source: US FDA. Licensed CC0.

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