Recall Z-1655-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Elekta XiO Radiation Treatment Planning System
| Date | May 26, 2010 (initiated Apr 15, 2010) |
| Status | Terminated |
| Reason | Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening |
| Root cause | Software design |
| Action | 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. |
| Quantity | The release is being used by 34 customers that also have an Elekta linear accelerator |
| Distribution | Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |