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Terminated

RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

FDA Recall Z-1081-2014 · Posted 2014-03-06

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-11-25
Date Terminated2015-08-13
Product Quantity489

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

Elekta sent an Important Field Safety Notice November 2013 to all affected customers. Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 041 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Important Field Safety Notice is in the process of being distributed to customers advising them of the recommended Quality Assurance checks to avoid/detect the problem. The permanent solution to this problem is currently been developed. Corrective Action #2 - Permanent Solution - All users of Desktop Pro software will be informed of a mandatory upgrade to Integrity 1.2 upon its release which will prevent calibration from being inverted. For questions regarding this recall call 770-300-9725.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982713RT DESKTOPElekta Oncology Systems, Ltd. · 1998-11-02

Official Source

View FDA Recall →

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

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