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Terminated

Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.

FDA Recall Z-1084-2014 · Posted 2014-03-06

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-11-25
Date Terminated2017-11-08
Product Quantity300

Reason for Recall

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Firm Action

Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 043 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Corrective Action #2 - Permanent Solution - All users of Integrity 3.1 software will be informed or a mandatory upgrade to Integrity 3.2 upon its release which will prevent calibration from being inverted. Target Release for Integrity 3.2 will be available at the end of February 2014.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121328AGILITYElekta , Ltd. · 2012-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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