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Terminated

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

FDA Recall Z-0928-2014 · Posted 2014-02-04

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-11-25
Date Terminated2015-12-02
Product Quantity1424

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102216XIO RTP SYSTEMComputerized Medical Systems, Inc. · 2010-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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