FDA-Device2013-03-06Class II

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

Elekta, Inc.
Hazard

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.

Sold states
Nationwide Distribution including TX
Affected count
1
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0885-2013

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