Elekta, Inc. recalls Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiati

Recalled March 12, 2014 · FDA recall Z-1082-2014 · Elekta

Hazard

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

Units

1309

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Elekta, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →