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Terminated

XiO Radiation Treatment Planning System, Release 4.51.00.

FDA Recall Z-1209-2010 · Posted 2010-03-25

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-02-22
Date Terminated2011-08-24
Product QuantityPlanning system is loaded 25 in locations

Reason for Recall

Inconsistent MLC positions, dose, and monitor units

Firm Action

Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.

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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