Recall Z-1231-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.
| Date | Apr 5, 2010 (initiated May 30, 2007) |
| Status | Terminated |
| Reason | There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate. |
| Root cause | Software design |
| Action | Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725. |
| Quantity | 18 units |
| Distribution | Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063512 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, Mar 5, 2007 |