Recall Z-0138-2014 ยท HAW Neurological Stereotaxic Instrument
Elekta, Inc.
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.
| Date | Nov 4, 2013 (initiated Jul 23, 2013) |
| Status | Terminated |
| Reason | Potential for clinical errors. |
| Root cause | No Marketing Application |
| 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. For further questions please call ( 770 ) 300-9725. |
| Quantity | 89 |
| 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 |