Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. For use in radiation treatment planning

FDA device recall Z-2572-2011 · posted 2011-06-15 · Terminated

Recall details

Recalling firm

Computerized Medical Systems Inc

Reason for recall

Focal: In absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and QA plan reflect blocked normalization. This is particularly important when these beams also include compensators. The problem is detectable by looking at the delivered dose to the weight point in the patient as

Action taken

Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008. 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

Status

Terminated

Product code

MUJ

Quantity affected

307

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Franc

Date initiated

2008-03-31

Date posted

2011-06-15

Date terminated

2014-04-09

Location

Maryland Heights, MO

Related 510(k) clearances