Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00. Product Usage: for use in radiation trea

FDA device recall Z-2599-2011 · posted 2011-06-20 · Terminated

Recall details

Recalling firm

Computerized Medical Systems Inc

Reason for recall

Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to

Action taken

Elekta CMS Software sent an "ADVISORY NOTICE" dated February 6, 2009 to its affected customers. The notice identified the product, the problem, and the actions to be taken. Customers were informed that the workaround method available is to (edit the MLC pattern using the aperture first and the individual MLC leaf edits second). The firm states that this issue will be resolved in Focal version 4.50.00 and above. A "User Notice" will be sent to all users still using the affected software notifying them of the updated software available to correct the problem. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

760

Distribution

Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina,

Date initiated

2009-02-06

Date posted

2011-06-20

Date terminated

2014-04-08

Location

Maryland Heights, MO

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