PlainRecalls
FDA Devices Moderate Class II Terminated

Monaco Product Usage: Planning of radiation therapy

Reported: July 18, 2012 Initiated: June 21, 2012 #Z-2007-2012

Product Description

Monaco Product Usage: Planning of radiation therapy

Reason for Recall

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Details

Recalling Firm
Elekta, Inc.
Units Affected
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
Location
Norcross, GA

Frequently Asked Questions

What product was recalled?
Monaco Product Usage: Planning of radiation therapy. Recalled by Elekta, Inc.. Units affected: 38.
Why was this product recalled?
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-2007-2012.