Recall Z-1232-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
| Date | Apr 5, 2010 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position. |
| Root cause | Software design |
| Action | Elekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725. |
| Quantity | 32 units |
| Distribution | Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, 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 |