Recall Z-0307-2012 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
| Date | Nov 30, 2011 (initiated Jun 23, 2011) |
| Status | Terminated |
| Reason | There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose. |
| Root cause | Labeling False and Misleading |
| Action | Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative. |
| Quantity | 2 |
| Distribution | Nationwide Distribution (USA) - including the states of: NM and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973441 | LEKSELL GAMMAPLAN Patterson Consulting Group, Inc., Apr 1, 1998 |