Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1082-2014)

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:

Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

Product Classification:

Class II

Date Initiated: November 25, 2013

Date Posted: March 12, 2014

Recall Number: Z-1082-2014

Event ID: 67223

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: 1309

Code Information:

Identifier - 6.0, 6.1.0, 7.0.1

Distribution Pattern:

Worldwide Distribution: US (nationwide): AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia & Herzego, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, South Korea, Spain, Sudan, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated