PlainRecalls
FDA Devices Moderate Class II Terminated

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Reported: September 19, 2012 Initiated: July 27, 2012 #Z-2340-2012

Product Description

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Reason for Recall

Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

Details

Recalling Firm
Elekta, Inc.
Units Affected
2
Distribution
Nationwide Distribution including DC & MD
Location
Norcross, GA

Frequently Asked Questions

What product was recalled?
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.. Recalled by Elekta, Inc.. Units affected: 2.
Why was this product recalled?
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 19, 2012. Severity: Moderate. Recall number: Z-2340-2012.