Recall Z-1066-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process.
| Date | Feb 21, 2012 (initiated Jan 26, 2012) |
| Status | Terminated |
| Reason | If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position. |
| Root cause | Software design |
| Action | ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 770-670-2548 |
| Quantity | 96 units |
| Distribution | Nationwide Distribution including AR, AZ, CA, CT, FL, GA, ID, IL, LA MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI, and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100115 | XVI R4.5 Elekta , Ltd., Mar 10, 2010 |