Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1081-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 25, 2013

Date Posted: March 12, 2014

Recall Number: Z-1081-2014

Event ID: 67217

Reason for Recall:

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

Status: Terminated

Product Quantity: 489

Code Information:

R4.2, R5.0, R5.1, R6.0, R6.1

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.

Voluntary or Mandated:

Voluntary: Firm initiated