Monaco Product Usage: Planning of radiation therapy
This recall has been terminated (originally issued July 12, 2012).
- Company
- Elekta, Inc.
- Recall Initiated
- June 21, 2012
- Posted
- July 12, 2012
- Terminated
- April 1, 2014
- Recall Number
- Z-2007-2012
- Quantity
- 38
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
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
Lot / Code Info
Version 3.10.00 - 3.20.00, inclusive
Root Cause
Software design
Action Taken
Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.
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