Recall Z-1223-2011 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell GammaPlan, Model 5.34. Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
| Date | Feb 14, 2011 (initiated Oct 1, 2005) |
| Status | Terminated |
| Reason | Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped. |
| Root cause | Other |
| Action | Product bulletin Leksell GammaPlan - "Leksell GammaPlan version 5.34" (dated October 2005) was sent to affected Customers as notification of the problem. Field Change Order FCO-DCO-05-0006 (dated November 22, 2005) and Technical Notes Leksell GammaPlan Leksell SurgiPlan Important Notice - "Potential issue using flipped angiographic images" (dated October 2005) was sent to Elekta Service Engineers as notification of the problem. The letters described the issue and the FCO asked the Service Engineers to confirm their receipt of the documentation. The Technical Notes also discussed image visua |
| Quantity | 272 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973441 | LEKSELL GAMMAPLAN Patterson Consulting Group, Inc., Apr 1, 1998 |