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Terminated

XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

FDA Recall Z-2568-2011 · Posted 2011-06-15

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product Codemuj
Date Initiated2009-05-13
Date Terminated2014-04-09
Product Quantity1116

Reason for Recall

In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.

Firm Action

Computerized Medical Systems, Inc. sent an CUSTOMER ADVISORY letter dated May 2009, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Computerized Medical Systems, Inc have created "patches" to resolve the problem. A User Notice was sent in March 2011, to all users still using the affected software notifying them of the updated software available to correct the problem. This letter was sent by US Mail but no return receipt was included. For further questions, please call (408) 380-8023.

Root Cause

Software design

Distribution Pattern

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