—#115627

Product

GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System

FDA product code: JAC — System, X-Ray, Film Marking, Radiographic
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: Model Number : 5271997

Why it was 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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare will, without charge, remedy the issue or bring the product into compliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue. Contact Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Nationwide Distribution including NM, WY, FL, MO, MA, and MI.

Timeline

Recall initiated: 2012-08-03
Posted by FDA: 2013-02-26
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.