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Terminated

Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data form a Windows-based PC and transfer the information back to the RTP system. It is intended for use in radiation treatment planning using generally accepted contouring methods.

FDA Recall Z-2562-2011 · Posted 2011-06-14

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-11-09
Date Terminated2014-04-02
Product Quantity155

Reason for Recall

Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment.

Firm Action

Elekta CMS Software sent a USER NOTICE dated November 5, 2010, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends to correct the software so it does not modify anything about the plan sent from XiO. Customers were instructed to contact their local customer support office with any questions.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Singapore, Slovenia, South Africa, Spain, Suriname, Switzerland, Taiwan, Turkey, Turkmenistan, and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013112FOCAL SIMComputerized Medical Systems, Inc. · 2001-12-05

Official Source

View FDA Recall →

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

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