Recall Z-0769-2016 ยท IZL System, X-Ray, Mobile
GE Medical Systems, LLC
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
| Date | Feb 8, 2016 (initiated Dec 23, 2015) |
| Status | Terminated |
| Reason | Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. |
| Root cause | Device Design |
| Action | Consignees were sent on 12/23/2015 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 10906 dated December 18, 2015. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers may continue to use the system. The firm will correct the affected devices and no charge to the customer; and a GE Healthcare representative will contact customers to arrange for the correction. For questions or |
| Quantity | 126 |
| Distribution | Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX Ge Medical Systems, LLC, Jun 16, 2011 |