FDAClass IISeptember 19, 2012

Multileaf Collimator To be used for single or multiple recall

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…

Why was Multileaf Collimator To be used for single or multiple recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

152599 and 152678

Product
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…
Recalling firm
Elekta, Inc.
Quantity
2
Distribution
Nationwide Distribution including DC & MD
Recall date
September 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls