—#125027

Product

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

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K102216
Affected lot / code info: MUJ

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

Corrective Action 1 - An important safety notice, LINXIO0018 - Incorrect Effective Depth for Bolused Beams is in the process of being distributed to affected customers. (Release date November 25, 2013). Corrective Action 2 - Develop a fix to the defect in an expeditious timeframe and make available in Patch Release 4.0.03 and Release 5.00.01.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2013-11-25
Posted by FDA: 2014-02-04
Terminated: 2015-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.