Recall Z-0761-2013 ยท JAC System, X-Ray, Film Marking, Radiographic
GE Healthcare, LLC
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
| Date | Feb 26, 2013 (initiated Aug 3, 2012) |
| Status | Terminated |
| 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. |
| 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 Representativ |
| Quantity | 9 units installed in US |
| Distribution | Nationwide Distribution including NM, WY, FL, MO, MA, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.