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Terminated

XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

FDA Recall Z-2574-2011 · Posted 2011-06-15

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product Codemuj
Date Initiated2008-05-14
Date Terminated2014-04-08
Product Quantity936

Reason for Recall

In XiO, when Telepathy is exited, re-entered, and the temporary plan re-called, the OLD beam weight will be displayed but the dose distribution will reflect the modified beam weight.

Firm Action

Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter to all affected customers in May 2008. The letter identified the product, the problem and the action needed to be taken by the customer. The issue was resolved in XiO Release 4.50.00 which has been available since June 2009. A User Notice was sent in March 2011, to all the customers reminding them of the availability of the correction. This notice was sent hardcopy via US Mail but there was no return receipt. For further questions, please call ( 408) 380-8023

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092132XIO RTP SYSTEMComputerized Medical Systems, Inc. · 2009-09-24

Official Source

View FDA Recall →

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

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