—#117819

Product

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 product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K121328
Affected lot / code info: 325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271

Why it was recalled

Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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

Timeline

Recall initiated: 2013-04-30
Posted by FDA: 2013-05-25
Terminated: 2017-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117819. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.