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Recall Observatory FDA recall evidence

Device product

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

Z-0130-2016

August 31, 2015

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 72223
Status
Terminated
Classification
Class II
Quantity
1440 units
Official record key
device-enforcement:Z-0130-2016

Official wording

Reason: Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Code information: Version 4.51 and higher

Distribution pattern: Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect Treatment Delivery Using Third Party Fixed Wedges.