Recall Z-1158-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
| Date | Mar 17, 2010 (initiated Jul 2, 2007) |
| Status | Terminated |
| Reason | Need to modify the closing speed of the shielding doors in the event of an emergency exit |
| Root cause | Other |
| Action | A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released. |
| Quantity | 19 |
| Distribution | Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063512 | LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB, Mar 5, 2007 |