Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System Recalled by GE Healthcare, LLC Due to GE Healthcare has become aware of a software...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.
Affected Products
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Quantity: 9 units installed in US
Why Was This Recalled?
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Healthcare, LLC
GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report