FDAClass IIOctober 2, 2013

Monaco RTP System Radiation Therapy Treatment Planning recall

Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

Why was Monaco RTP System Radiation Therapy Treatment Planning recalled?

Patient needs to be positioned as indicated by the treatment plan.

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?

All versions of Monaco

Product
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Recalling firm
Elekta, Inc.
Quantity
72
Distribution
Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
Recall date
October 2, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls