Recall Z-1405-2015 ยท IZL System, X-Ray, Mobile
GE Healthcare
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
| Date | Apr 27, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on |
| Quantity | 6 units US |
| Distribution | US Distribution to the states of: AZ, FL, GA, MO and WI. |
| 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 |