GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
FDA Recall Z-0840-2015 · Posted 2015-01-13
Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOXO
Date Initiated2014-09-15
Date Terminated2015-05-20
Product Quantity61 units installed in US
Reason for Recall
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
Firm Action
Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will, without charge, perform a mA calibration on all affected systems in the USA to bring the product back into compliance. The details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit.
Should customers have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.