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

FDA device recall Z-0761-2013 · posted 2013-02-26 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

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.

Action taken

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

Status

Terminated

Product code

JAC

Quantity affected

9 units installed in US

Distribution

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

Date initiated

2012-08-03

Date posted

2013-02-26

Date terminated

2013-12-05

Location

Waukesha, WI