Elekta XiO Radiation Treatment Planning System
FDA Recall Z-1655-2010 · Posted 2010-05-26
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Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-04-15
Date Terminated2012-06-07
Product QuantityThe release is being used by 34 customers that also have an Elekta linear accelerator
Reason for Recall
Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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