Monaco Product Usage: Planning of radiation therapy recall
Monaco Product Usage: Planning of radiation therapy
Why was Monaco Product Usage: Planning of radiation therapy recalled?
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
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?
Version 3.10.00 - 3.20.00, inclusive
- Product
- Monaco Product Usage: Planning of radiation therapy
- Recalling firm
- Elekta, Inc.
- Quantity
- 38
- Distribution
- US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)