Recall Z-1252-2011 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Feb 15, 2011 (initiated Jan 5, 2011) |
| Status | Terminated |
| Reason | Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180. |
| Root cause | Other |
| Action | The firm, Elekta Limited, sent an "Important Notice A344" dated January 5, 2011 to all consignees/customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to follow any instructions or recommendations covered in the notice. The notice provides suggestions on how to check and prevent this situation from occurring; it instructs the User to file the document in the Important Notice section of the appropriate User Manual; to complete a FlexMap Check each time they acquire a new FlexMap and amend their local procedures to include |
| Quantity | 223 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc., Aug 12, 2005 |