Elekta XiO Radiation Treatment Planning System
This recall has been terminated (originally issued May 26, 2010).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- April 15, 2010
- Posted
- May 26, 2010
- Terminated
- June 7, 2012
- Recall Number
- Z-1655-2010
- Quantity
- The release is being used by 34 customers that also have an Elekta linear accelerator
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening
Distribution
Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
Lot / Code Info
Release 4.50.00 and above
Root Cause
Software design
Action Taken
Elekta issued an undated "Important Safety Notice" to all affected sites via e-mail on 4/20/2010. The notice was also sent to the sites on 4/6/10 and 4/12/10 (for 4 sites) before the firm made the decision to recall. The letter explains the correct functioning of the system, the problem, when and why it occurs, the clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed postcard was enclosed for the customer to return as evidence they received and understood the notice. Sites that do not return the card will be contacted by phone.