XiO Radiation Treatment Planning System, Release 4.51.00.
This recall has been terminated (originally issued March 25, 2010).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- February 22, 2010
- Posted
- March 25, 2010
- Terminated
- August 24, 2011
- Recall Number
- Z-1209-2010
- Quantity
- Planning system is loaded 25 in locations
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Inconsistent MLC positions, dose, and monitor units
Distribution
Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
Lot / Code Info
Release 4.51.00
Root Cause
Software design
Action Taken
Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
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