Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
FDA Recall Z-1402-2013 · Posted 2013-05-25
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-04-30
Date Terminated2017-07-26
Product Quantity31
Reason for Recall
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Firm Action
Elekta sent an Important Field Safety Notice (IFSN) letter dated April 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the FCO Action Notification Report to local Elekta Office or Representative.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA Nationwide including the states of CA, FL, IL, MD, MA, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VA, WA, DC and Puerto Rico
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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