—#115573

Product

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

FDA product code: IXI — Block, Beam-Shaping, Radiation Therapy
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111676
Affected lot / code info: 152652

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Nationwide Distribution including TX

Timeline

Recall initiated: 2013-01-18
Posted by FDA: 2013-02-26
Terminated: 2014-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.