Brivo XR385 — Class II medical device recall Z-2523-2018
Terminated recall by GE Healthcare, LLC, reported 2018-08-01, distributed in AK, AL, AZ, CA, CT, FL, GA, GU…. The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce imag
| Recall number | Z-2523-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-09-16 |
| Classified | 2018-07-20 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2018-07-26 |
| Distributed | AK, AL, AZ, CA, CT, FL, GA, GU, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA |
| Countries outside the US | CA |
| Model numbers | 5215463 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2523-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.