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U.S. Department of Health and Human Services

Class 2 Device Recall PrecisePLAN Treatment Planning System

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  Class 2 Device Recall PrecisePLAN Treatment Planning System see related information
Date Initiated by Firm February 05, 2008
Date Posted March 04, 2011
Recall Status1 Terminated 3 on April 07, 2011
Recall Number Z-1556-2011
Recall Event ID 57693
510(K)Number K022411  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product PrecisePLAN Treatment Planning System

Intended use: To plan multiple beam radiation therapy treatments.
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Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 282 units
Distribution Worldwide distribution: USA and country of: Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = PRECISION THERAPY INTL., INC.
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