Recall Z-1604-2010 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists
| Date | May 14, 2010 (initiated Jan 7, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Phase 1 - Important Notice and Technical Note #200 058 - "Accuracy problems in Leksell GammaPlan 8.0 image fusion", dated December 10.2007 and Field Change Order #200 058, "Technical Note: Accuracy problems in Leksell Gamma Plan 8.0 image fusion", dated January 7, 2008 were sent to affected customers and all field service engineers as notification of the problem. The notice describes the product, problem and actions to be taken by customers. The firm recommended that the customers not use the fusion function until their Leksell GammaPlan(R) is upgraded to version 8.2. For further question, |
| Quantity | 66 units |
| Distribution | Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IL MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, 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 |