Recall Z-0319-2012 ยท HAW Neurological Stereotaxic Instrument
Elekta, Inc.
Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions.
| Date | Nov 30, 2011 (initiated Mar 25, 2011) |
| Status | Terminated |
| Reason | Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems. |
| Root cause | Under Investigation by firm |
| Action | Elekta sent an IMPORTANT NOTICE letter dated March 25, 2011 to all affected customers. The letter identified the affected product, the problem, key safety procedures and information to users for safe operation of the Stereotactic Circular Collimator. Elekta will issue a Mandatory Action Field Change Order which will include an updated Circular Collimator Instructions for Use - 102022201 and new labels. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. Also, Elekta is offering some free WebEx sessions which will include the proce |
| Quantity | 89 devices |
| Distribution | Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011255 | 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D Line USA, Inc., Dec 20, 2001 |