System, Radiation Therapy, Radionuclide

Brand Name: Leksell Gamma Knife

Due to adapter not being properly aligned or locked in place.

GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System.

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimet

If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.

Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.

Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Laksell Gamma Knife Perfexion

Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

Elekta Leksell Gamma Plan

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.

Elekta Leksell Gamma Knife C 1.2, 4 and 4C

Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.

Leksell GammaPlan, Model 5.34.

Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.

Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.

The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.

Leksell GammaPlan 8.0 image fusion

The precision of the calculation used to create the fused study in LGP 8.0 is too low and should not be used until the system is upgraded to LGP 8.2.