Recall Z-0885-2013 ยท IXI Block, Beam-Shaping, Radiation Therapy
Elekta, Inc.
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
| Date | Feb 26, 2013 (initiated Jan 18, 2013) |
| Status | Terminated |
| Reason | If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions. |
| Root cause | Employee error |
| Action | Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725. |
| Quantity | 1 |
| Distribution | Nationwide Distribution including TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111676 | APEX Elekta Limited, Sep 30, 2011 |