Recall Z-1411-2010 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Apr 22, 2010 (initiated Sep 19, 2007) |
| Status | Terminated |
| Reason | Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction. |
| Root cause | Device Design |
| Action | The following Important Notices were sent to customers: 1) Important Notice A305-Possible Synergy XVI panel position error (dated September 19, 2007) was sent to customers with versions R3.5, R4.0 and R4.1., 2) Important Notice A306-Possible Synergy XVI panel positioning error (dated November 8, 2007) was released to encompass customers with version R4.2., and 3) Important Notice A328 dated March 10, 2009, and sent again on April 29, 2009, included a modification kit to address the original issue and an expanded range of serial numbers affected. This Important notice A328 entitled, Elekta Syn |
| Quantity | 166 units |
| Distribution | Worldwide distribution: USA and Puerto Rico, Canada and Mexico. |
| 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 |