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Recall Observatory FDA recall evidence

Device product

Focal Sim radiation therapy treatment planning system

Z-1244-2015

December 19, 2014

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 70433
Status
Terminated
Classification
Class II
Quantity
907
Official record key
device-enforcement:Z-1244-2015

Official wording

Reason: Incorrect CT to ED when using the Monaco Image Statistics Tool.

Code information: Focal Release 4.80

Distribution pattern: Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect CT to ED when using the Monaco Image Statistics Tool.