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Class 2 Device Recall PrecisePLAN 2.10 Treatment Planning System |
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Date Initiated by Firm |
March 15, 2006 |
Date Posted |
April 16, 2010 |
Recall Status1 |
Terminated 3 on December 30, 2010 |
Recall Number |
Z-1406-2010 |
Recall Event ID |
55100 |
510(K)Number |
K022411
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Product Classification |
Medical changed particle radiation therapy system - Product Code MUJ
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Product |
PrecisePLAN 2.10 Treatment Planning System |
Code Information |
1762685762, 1762688017, 1762688506, 1726288507, 1762676911, 1762688175, 1762689384, 1762688019, 1762688022, 1762688876, 1762689442, 1762688177, 1762690813, 1762686657, 1762689588, 1762689386, 1762684357, 1762686833, 1762684370, 1762678238, 1762689519, 1762684359, 1762690814, 1762688514, 1762578223, 1762678239, 1762684360, 1762684361, 1762684362, 1762684367, 1762683737, 1762682414, 1762688081, 1762686584, 1762686843, 1762686832, 1762688024, 1762688080, 1762686836, 1762684358 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 4775 Peachtree Industrial Blvd Bldg 300, #300 Norcross GA 30092-3011
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For Additional Information Contact |
Thomas Valentine 770-670-2548
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Manufacturer Reason for Recall |
Error in dose rates which were calculated at exactly twice the expected values.
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FDA Determined Cause 2 |
Software design |
Action |
As described in a prior related submission, Phase I - "Important Notice A285, Scrolling Selected Frame Dose Calculator Error" dated March 15, 2006 was distributed to affected customers to inform them of the potential and what steps should be taken.
Phase 2 -- Software release PrecisePLAN 2.11 was released July 11, 2006 to correct this problem. All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006.
Phase 3 -- All customers with PrecisePLAN 2.10 will be upgraded to the revised software PrecisePLAN 2.11 through Field Change Order #772 00 540 052 dated June 5, 2006. The company is directing questions to the local Electa representative or to their offices in the U.K. at telephone 44 (0)-1293-654200. |
Quantity in Commerce |
40 units |
Distribution |
Worldwide: IL, NY, PA, TN, Canada, China, Czech Republic, Germany, India, Israel, Italy, Mexico, Poland, Russia, Spain, Switzerland |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MUJ and Original Applicant = PRECISION THERAPY INTL., INC.
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