All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Recall Z-1065-2014 · Posted 2014-03-07
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-05-28
Date Terminated2021-09-15
Product Quantity472 units
Reason for Recall
Customers are resetting the default values outside recommended factory settings.
Firm Action
Elekta sent an Important Field Safety Notice dated May 2013 to all affected customers. The Notice identified the affected product, problem, clinical impact and actions to be taken. Customers were instructed to adhere to the instructions and advice given in manuals and system dialogues. For question contact your local Elekta office.
Root Cause
Device Design
Distribution Pattern
USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC and including 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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