Elekta XiO Radiation Treatment Planning System 의 리콜

Recall

55361

Class 2

Z-1655-2010

2010-04-15

2010-05-26

Terminated

United States

2012-06-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90674

Under certain circumstances, xio will over-estimate dose in the region where the backup jaw is inside the mlc opening.

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.