FDAClass IIOctober 2, 2013

Monaco RTP System Radiation treatment planning recall

Monaco RTP System Radiation treatment planning

Why was Monaco RTP System Radiation treatment planning recalled?

Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.

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 3.10.00 and later

Product
Monaco RTP System Radiation treatment planning
Recalling firm
Elekta, Inc.
Quantity
45
Distribution
Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
Recall date
October 2, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls