GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
FDA Recall Z-0761-2013 · Posted 2013-02-26
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAC
Date Initiated2012-08-03
Date Terminated2013-12-05
Product Quantity9 units installed in US
Reason for Recall
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.
Firm Action
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
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.