FDAClass IIFebruary 27, 2013

Monaco RTP System. Radiation treatment planning recall

Monaco RTP System. Radiation treatment planning.

Why was Monaco RTP System. Radiation treatment planning recalled?

The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.

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?

Versions 3.20.00 and 3.20.01

Product
Monaco RTP System. Radiation treatment planning.
Recalling firm
Elekta, Inc.
Quantity
13
Distribution
Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
Recall date
February 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls