Recall Z-1251-2011 ยท HAW Neurological Stereotaxic Instrument
Elekta, Inc.
Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.
| Date | Feb 15, 2011 (initiated Oct 2, 2009) |
| Status | Terminated |
| Reason | New protocols for MR sequences may result in higher RF energies deposited during MR scanning, generating heat in uninsulated fixation posts. |
| Root cause | Labeling design |
| Action | Elekta sent Important Notice Affected Product: Fixation Posts, A331, dated June 22, 2009. The Important Notice will be added to the Customer User manual upon receipt. |
| Quantity | 379 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972324 | LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB, Mar 2, 1998 |