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Recall Observatory FDA recall evidence

Device product

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

Z-1082-2014

November 25, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 67223
Status
Terminated
Classification
Class II
Quantity
1309
Official record key
device-enforcement:Z-1082-2014

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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