Recall Z-1402-2013 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
| Date | May 25, 2013 (initiated Apr 30, 2013) |
| Status | Terminated |
| Reason | Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0. |
| Root cause | Nonconforming Material/Component |
| Action | Elekta sent an Important Field Safety Notice (IFSN) letter dated April 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the FCO Action Notification Report to local Elekta Office or Representative. |
| Quantity | 31 |
| Distribution | USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121328 | AGILITY Elekta , Ltd., Jun 12, 2012 |