Elekta, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1402-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 30, 2013

Date Posted: June 5, 2013

Recall Number: Z-1402-2013

Event ID: 65060

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.

Status: Terminated

Product Quantity: 31

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

Voluntary or Mandated:

Voluntary: Firm initiated