Elekta, Inc. recalls Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear a

Recalled March 12, 2014 · FDA recall Z-1083-2014 · 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

455

Sold at

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, 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

Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.

Manufacturer(s)

Elekta, Inc.

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