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Recall Observatory FDA recall evidence

Device product

XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

Z-0928-2014

November 25, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 67224
Status
Terminated
Classification
Class II
Quantity
1424
Official record key
device-enforcement:Z-0928-2014

Official wording

Reason: When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

Code information: MUJ

Distribution pattern: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, QA, WA, WV, WI, and WY, and the countries of Albania, Algeria, Argentina, Austria, Australia, Bosnia, Bulgaria, Belgium, Bahrain, Brazil, Belarus, Botswana, Bangladesh, Canada, China, Columbia, Costa Rica, Croatia, Cuba, Cyprus, Chile, Czech Republic, Ecuador, Egypt, Estonia, France, Finland, Gabon, Germany, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Italy, Ireland, Israel, Iraq, Jordan, Japan, Kosovo, Kuwait, Lithuania, Libya, Latvia, Morocco, Malaysia, Malta, Mexico, Myanmar, Netherland, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sudan, Syria, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, Venezuela, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.