FDAClass IIMarch 6, 2013

Elekta recall

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

Why was Elekta 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.

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?

152652

Product
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Recalling firm
Elekta, Inc.
Quantity
1
Distribution
Nationwide Distribution including TX
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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