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

Date

March 6, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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

Reason

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.

Distribution pattern

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

Quantity

9 units installed in US

Codes and lots

Model Number : 5271997

Recall started

Aug. 3, 2012

Device type

System, X-Ray, Film Marking, Radiographic

Root cause (FDA)

Radiation Control for Health and Safety Act

What the company told customers

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

Recall number

Z-0761-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0761-2013. The agency record governs; check it and the company before acting.