Z-0761-2013Class II

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

Name: Z-0761-2013 GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Creator: GE Healthcare, LLC
Published: 2012-08-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-08-03 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System on 2012-08-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0761-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-03
Posted: 2013-02-26
Terminated: 2013-12-05
Recalling firm: GE Healthcare
Product: GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Product code: JAC System, X-Ray, Film Marking, Radiographic
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
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
Quantity in commerce: 9 units installed in US
Distribution: Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
Product codes and lots: Model Number : 5271997

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0761-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0761-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code JAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)