Class 2 Device Recall Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2

• Date Initiated by Firm: August 23, 2007
• Date Posted: March 04, 2011
• Recall Status: Terminated on April 07, 2011
• Recall Number: Z-1555-2011
• Recall Event ID: 57688
• 510(K)Number: K982713
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Code Information: 134615, 134621, 134091, 136364, 134172, 136285, 134605, 134183, 136167, 136234, 134259, 134115, 134081, 136047, 136063, 134701, 134328, 134391, 134432, 134436, 134438, 136119, 134535, 134561, 134475, 134564, 134154, 134269, 134348, 134399, 136084, 136087, 136100, 134200, 134118, 134822, 134018, 136368, 134241, 134606, 134711, 134473, 134787, 134768, 134571, 134237, 134104, 136009, 134331, 134272, 136322, 136175, 136200, 134503, 136257, 134322, 134781, 134380, 134709, 136108, 134250, 134254, 134258, 134206, 134195, 134094, 134652, 134704, 136107, 134469, 134472, 134483, 134519, 134729, 136109, 134236, 134239, 134197, 134456, 134047, 134092, 134211, 136373, 134275, 134679, 136106, 136163, 134667, 136181, 134169, 134329, 134126, 134090, 134358, 134427, 134626, 134819, 134027, 134265, 134597, 136319, 134220, 134256, 134396, 134804, 134235, 136338, 134137, 134234, 134249, 136034, 136065, 136110, 136267, 136291, 134213, 134219, 136330, 134750, 136097, 136270, 134457, 134078, 134129, 136195, 134375, 134603, 136074, 134075, 134565, 134196, 134428, 134430, 134008, 134382, 134070, 134157, 134772, 136080, 134860, 134401, 134368, 134388, 134631, 134318, 136015, 136096, 134563, 136165, 136240, 134441, 134017, 134048, 134189, 134395, 134324, 134595, 134140, 134212, 136086, 134354, 136178, 136317, 136318, 134445, 136012, 136332, 134321, 136071, 136089, 136292, 136293, 134673, 134685, 136059, 136169, 134073, 134748, 134754, 134378, 134383, 134458, 134192, 134499, 136069, 136092, 134642, 134295, 134671, 136046, 136147, 134062, 136049, 136036, 136152, 136157, 136083, 136081, 134770, 136118, 136156, 136172, 134352, 134548, 134533, 136153, 136269, 136197, 136252, 136286, 136315, 136241, 134811, 134812, 136258, 136312, 134069, 136310, 134864, 134040, 134046, 134307
• FEI Number: 1037831
• 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: Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table.
• FDA Determined Cause: Other
• Action: The firm, Elekta, sent an "Important Notice A302" dated August 23, 2007 titled "Update to iCom Tables for Desktop Pro when used with Third Party R&V Systems",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to be 3.0 degrees-no less than 3.0 and to use the Linac Record, if configured, as a means of checking the final collimator position. Elekta noted that the issue will be resolved in a future release of Desktop Pro. If you any questions related to this issue, please contact your local Elekta, third party R&V system representative or Elekta Limited at +44 (0)1293 654200.
• Quantity in Commerce: 229 units
• Distribution: Worldwide distribution: USA including Puerto Rico and countries including: Canada and 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 = IYE