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.
FDA Recall Z-0319-2012 · Posted 2011-11-30
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2011-03-25
Date Terminated2012-10-02
Product Quantity89 devices
Reason for Recall
Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.
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 procedures and recommended operation of these types of accessories. Customers are instructed to register at www.elekta.com/SafeAccessories.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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