Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
FDA Recall Z-0138-2014 · Posted 2013-11-04
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2013-07-23
Date Terminated2014-11-18
Product Quantity89
Reason for Recall
Potential for clinical errors.
Firm Action
Elekta sent an Important Field Safety Notice dated 7/2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were advised of the issue and recommendation to resolve either by upgrading their system or to discontinue a clinical use of the device.
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Root Cause
No Marketing Application
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.