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Terminated

Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00. For use in radiation treatment planning using generally accepted contouring methods. The Focal software 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 from a Windows-based PC and transfer the information back to the RTP system.

FDA Recall Z-2559-2011 · Posted 2011-06-14

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2009-06-12
Date Terminated2014-04-09
Product Quantity462

Reason for Recall

Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.

Firm Action

Computerized Medical System sent a CUSTOMER ADVISORY dated June 12, 2009, to all affected users. This advisory identified the product, the problem, and the action needed to be taken by the customer. There were no patients mistreated as a result of this issue The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403 ) 830-8023

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including Puerto Rico, and the countries of Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, Nicaragua, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, and Venezuela.

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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