Recall Z-2340-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
| Date | Sep 10, 2012 (initiated Jul 27, 2012) |
| Status | Terminated |
| Reason | Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex. |
| Root cause | Error in labeling |
| Action | ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility. For questions regarding this recall call 770-300-9725. |
| Quantity | 2 |
| Distribution | Nationwide Distribution including DC & MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121328 | AGILITY Elekta , Ltd., Jun 12, 2012 |