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Recall Observatory FDA recall evidence

Device 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.

Z-1402-2013

April 30, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 65060
Status
Terminated
Classification
Class II
Quantity
31
Official record key
device-enforcement:Z-1402-2013

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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