Recall Z-2523-2018 ยท KPR System, X-Ray, Stationary
GE Healthcare, LLC
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
| Date | Jul 16, 2018 (initiated Sep 16, 2016) |
| Status | Terminated |
| Reason | The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes. |
| Root cause | Component change control |
| Action | An Important Electronic Product Radiation Warning letter was sent to consignees beginning 9/16/2016. The letter identified affected product, described the issue, and stated that GE will correct the devices without charge. Questions can be directed to 1-800-437-1171. |
| Quantity | 58 (55 US, 3 OUS) |
| Distribution | AK, AL, AZ, CA, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MS, NJ, NM, OR, PA, TN, TX, VA, and Guam, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103448 | BRIVO XR385 Ge Medical Systems, LLC, Aug 12, 2011 |