The Recall Desk
ModerateFDA (Devices)·Z-0761-2013·Announced 2013-03-06

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.

What this means for you

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
Category
Medical Device — Radiology Equipment
Hazard
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

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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