GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- September 15, 2014
- Posted
- January 13, 2015
- Terminated
- May 20, 2015
- Recall Number
- Z-0840-2015
- Quantity
- 61 units installed in US
- Firm Location
- Salt Lake City, UT
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).
Distribution
Worldwide Distribution
Lot / Code Info
GE OEC Brivo 715 Prime Serial Numbers: B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.