PrecisePLAN Treatment Planning System Intended use: To plan multiple beam radiation therapy treatments.
FDA Recall Z-1556-2011 · Posted 2011-03-04
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2008-02-05
Date Terminated2011-04-07
Product Quantity282 units
Reason for Recall
When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.
Firm Action
The firm, Elekta, sent an "Important Notice A312" titled "Unintentional Modification of a locked fraction group in PrecisePLAN" dated February 5, 2008 to all affected customers. The notice described the product, problem and action to be taken. The customers were instructed to use care when using the "Make Opposed" function and when changing the Fraction Group of a beam. The customers were also advised to review the final plan and any locked fraction groups to make sure the planned beam arrangement is what was intended.
Note: A Field Change Order 540 073 "All PrecisePLAN 2.15 users" was issued on September 30, 2008 to all customers.
If you have any questions, call 770-670-2548 or +44(0)1293 654400.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA and country of: Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.