Recall Z-1230-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
| Date | Apr 5, 2010 (initiated Nov 9, 2008) |
| Status | Terminated |
| Reason | Radiation unit doors could close too fast on emergency exit. |
| Root cause | Software design |
| Action | Field Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product. For further information, contact Elekta, Inc. at 1-770-300-9725. |
| Quantity | 19 units |
| Distribution | Nationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, 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 |