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Recall Observatory FDA recall evidence

Device product

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

Z-1083-2014

November 25, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 67184
Status
Terminated
Classification
Class II
Quantity
455
Official record key
device-enforcement:Z-1083-2014

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: Model 1.1

Distribution pattern: 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.

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.