GE Healthcare Recalls Brivo XR385 X-Ray Systems Due to Software Issue
GE Healthcare is recalling nine Brivo XR385 X-Ray systems in the US due to a software issue affecting visual indications required by regulations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, and the issue is a software compliance defect rather than a direct physical hazard, fitting the Moderate criteria for low-risk issues.
Plain-English summary
GE Healthcare, LLC is recalling nine units of the Brivo XR385 DR-F/ X-Ray System (Model 5271997) installed in the United States. The recall is due to a software issue on the product interface related to visual indications mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
The affected units were distributed nationwide, including in New Mexico, Wyoming, Florida, Missouri, Massachusetts, and Michigan. The source text does not report any illnesses or injuries associated with this software issue.
Healthcare facilities with this equipment should contact GE Healthcare for further instructions on resolving the software issue.
The recalled product
- Product
- GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number : 5271997
Distribution
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