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Terminated

XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

FDA Recall Z-2577-2011 · Posted 2011-06-16

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2008-04-08
Date Terminated2014-04-08
Product Quantity75

Reason for Recall

XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.

Firm Action

The firm, CMS, Inc., sent a "XiO Customer Advisory" letter dated April 8, 2008 to all affected customers. The letter describes the product, the problem, and the actions to be taken ( workaround). The letter also states the problem will be resolved in a future release. No release number or date was given. If you have any questions, please call 408-380-8023.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.

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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